U.S. patent application number 14/780195 was filed with the patent office on 2016-02-25 for system for identifying a dialyzer apparatus or a component thereof, and sensor device which can be used for this purpose.
The applicant listed for this patent is B. BRAUN AVITUM AG. Invention is credited to Silvie KRAUSE, Christof STROHHOFER.
Application Number | 20160051742 14/780195 |
Document ID | / |
Family ID | 50424230 |
Filed Date | 2016-02-25 |
United States Patent
Application |
20160051742 |
Kind Code |
A1 |
STROHHOFER; Christof ; et
al. |
February 25, 2016 |
SYSTEM FOR IDENTIFYING A DIALYZER APPARATUS OR A COMPONENT THEREOF,
AND SENSOR DEVICE WHICH CAN BE USED FOR THIS PURPOSE
Abstract
A system for acquiring or measuring information relating to a
state of dialysance, identifying a dialyzer apparatus, or
identifying a membrane filter device during the operation of the
dialyzer apparatus in a dialysis treatment of a patient. The
dialyzer apparatus includes a housing having an internal volume
portion and a membrane filter device arranged within the internal
volume portion. The housing allows transmission of radiation. A
sensor device connected to the housing of the dialyzer apparatus
includes a signal receiving device designed to receive a radiation
signal from the housing, the signal characteristic of the state or
the identification of the dialyzer apparatus or of the membrane
filter unit of the dialyzer apparatus.
Inventors: |
STROHHOFER; Christof;
(KASSEL, DE) ; KRAUSE; Silvie; (MELSUNGEN,
DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
B. BRAUN AVITUM AG |
Melsungen |
|
DE |
|
|
Family ID: |
50424230 |
Appl. No.: |
14/780195 |
Filed: |
March 27, 2014 |
PCT Filed: |
March 27, 2014 |
PCT NO: |
PCT/EP2014/056214 |
371 Date: |
September 25, 2015 |
Current U.S.
Class: |
210/85 ; 210/143;
210/96.2 |
Current CPC
Class: |
A61M 2205/52 20130101;
A61M 2205/3313 20130101; A61B 5/14557 20130101; A61M 2205/3306
20130101; A61M 1/1605 20140204; A61M 2205/60 20130101; A61M
2205/3569 20130101; A61M 1/3609 20140204; A61M 2205/3317 20130101;
A61M 1/367 20130101; A61M 1/1603 20140204; A61M 1/16 20130101; A61M
2205/6054 20130101; A61M 2205/6072 20130101; A61M 1/3406 20140204;
A61M 2230/20 20130101; A61M 1/1601 20140204; A61M 1/34 20130101;
A61M 2205/6063 20130101 |
International
Class: |
A61M 1/16 20060101
A61M001/16 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 3, 2013 |
DE |
10 2013 103 336.9 |
Claims
1-25. (canceled)
26. An identification device for a dialyzer apparatus or a membrane
filter device having a housing provided with an identification unit
containing an identifying feature that is characteristic for the
dialyzer apparatus or membrane filter device, the identification
device comprising: a sensor device in the form of a clip that is
adapted to read the identifying feature contained in the
identification unit and that is configured for direct connection in
a removable fashion to the housing and that comprises a signal
receiving unit configured to receive at least one signal from the
housing, from an outside or edge region of the housing, or from an
internal volume portion of the housing, wherein the dialyzer
apparatus or the membrane filter device is configured such that the
sensor device is able to detect or measure the at least one signal,
which corresponds to the identifying feature, such that an
identification of at least one of the dialyzer apparatus or a
component of the dialyzer apparatus may occur; and an analysis unit
configured to generate data based on the received at least one
signal for identifying or controlling operating parameters of a
dialysis machine.
27. The identification device according to claim 26, wherein the
signal receiving unit is configured to receive or detect signals of
radiation selected from a group that comprises the following: a)
electromagnetic radiation of the entire electromagnetic spectrum,
b) electromagnetic radiation having a wavelength or a frequency
corresponding thereto in the microwave range, in the terahertz
range, or in the range of radio waves; and c) ultrasound
radiation.
28. The identification device according to claim 26, wherein the
sensor device comprises a radiation transmitting unit configured to
transmit radiation onto the housing or into the internal volume
portion of the housing of the dialyzer apparatus, and wherein the
signal receiving unit is configured to measure one or more
parameters of received radiation.
29. The identification device according to claim 26 wherein the
dialyzer apparatus or the component comprises a passive
identification unit that comprises an identification feature
characteristic for the identification of the dialyzer apparatus or
the component and that may be read by irradiating the
identification unit with a predetermined electromagnetic radiation;
wherein the sensor device comprises a radiation transmitting unit
configured to transmit the predetermined electromagnetic radiation
to the identification unit; and wherein the signal receiving unit
comprises an identification reading unit configured to detect a
parameter of the radiation that is indicative of the identification
feature and to determine the identification feature.
30. The identification device according to claim 26, wherein the
dialyzer apparatus or the component comprises an active
identification unit, such as an active radio frequency
identification (RFID) chip, that is configured to transmit
electromagnetic radiation having an identification feature that is
characteristic for the identification of the dialyzer apparatus or
the component; and wherein the signal receiving unit comprises an
identification reading unit that is designed to detect the
electromagnetic radiation transmitted by the identification unit
and determine the identification feature.
31. The identification device according to claim 28, wherein the
radiation transmitting unit comprises at least one or more of the
following features: a light source that transmits light in a
narrow-band spectral range; a light-conducting fiber that guides
light transmitted by a light source emitting light in a narrow-band
spectral range and comprises a decoupling segment from which the
light exits; a light source that transmits light in a wide-band
spectral range; or a light-conducting fiber that guides light
transmitted by a light source emitting light in a wide-band
spectral range and comprises a decoupling segment from which the
light exits.
32. The identification device according to claim 26, wherein the
sensor device comprises a radiation measuring unit having at least
one radiation entrance region and at least one light detector
configured to detect radiation that has entered into the at least
one radiation entrance region, the at least one light detector
selected from a group that includes one or more of the following
features: one or more photodiodes; one or more phototransistors;
one or more complementary metal oxide semiconductor (CMOS) light
detectors; one or more photomultipliers; one or more avalanche
photodiodes; one or more one-dimensional or two-dimensional charge
coupled device (CCD) sensors; one or more one-dimensional or
two-dimensional CMOS sensors; one or more one-dimensional
arrangements or one or more two-dimensional arrangements of a
plurality of photodiodes, phototransistors, CMOS light detectors,
photomultipliers, or avalanche photodiodes; or one or more multi
photon pixel counters (MPPCs).
33. The identification device according claim 26, wherein the
sensor device comprises a radiation measuring unit having at least
one light detector and a wavelength selection unit, the wavelength
selection unit configured to select a narrow-band wavelength range
including a reference wavelength range from the wider-band
wavelength range of the radiation emitted by the radiation
transmitting unit on a transmitting side or on a receiving side
such that an optical interaction occurs with a selected material
located during operation on or in the dialyzer apparatus or in the
internal volume portion of the housing.
34. The identification device according to claim 26, wherein the
housing is designed such that the sensor device may be fixed in a
detachable fashion in one or more predetermined positions relative
to the housing.
35. The identification device according to claim 34, wherein the
housing comprises first coupling regions at one or more positions
on an exterior of the housing and the sensor device comprises a
second coupling region configured to engage in a positive fit with
one of the first coupling regions.
36. The identification device according to claim 26, wherein the
sensor device is integrated into a housing holder for holding a
dialyzer apparatus.
37. The identification device according to claim 26, wherein the
sensor device comprises a releasable fastening unit that is
detachably connected to a housing of a dialyzer apparatus and
comprises at least one sensor for detecting a signal originating
from the housing.
38. The identification device according to claim 37, further
comprising at least one radiation transmitter for transmitting
radiation onto the surface of the dialyzer apparatus or into the
interior of the dialyzer apparatus, the sensor device configured to
be reusable.
39. The identification device according to claim 37, further
comprising at least one of the following mechanisms for removably
attaching the sensor device to the housing: the sensor device is
embodied as a clip unit having at least one flexible clip arm or
clip cuff, where the clip arm or clip cuff is configured to
encompass the housing in an angular range of more than 180.degree.;
the sensor device comprises a base body and a clip unit having at
least one elastically flexible clip arm attached to the base body
or elastically flexible clip arm articulated on the base body
configured to encompass the housing at least partially, to enter
into a fixed, removable connection therewith, or to encompass the
housing in a clip-like fashion; the sensor device comprises a first
member of a connector unit and the dialyzer apparatus comprises a
second member of the connector unit, the first member configured to
engage the second member or the second member configured to engage
the first member in a removable positive fit; the sensor device is
clamped on the housing by an elastic clamping unit with the
clamping unit configured to encompass the sensor device and the
housing of the dialyzer apparatus in a clamped state; the sensor
device comprises a base body and at least one arm or cuff
articulated on the base body or connected to the base body in an
elastically flexible fashion, each comprising a distal end region
having a first member of a hook or engaging unit provided thereon,
with the arm or cuff being configured to encompass the housing in
an angular range of more than 180.degree., and an elastically
tensible clamping unit having end sections opposite one another, on
each of which a second member of a hook or engaging unit is
provided that is configured to detachably engage a first member of
the hook or engaging unit, with each second member on the end
section of the clamping unit configured to engage with a first
member on the end regions of the arms and/or clamps of the sensor
device; or the sensor device is configured to be integrated into
the housing wall of the dialyzer apparatus in a removable
fashion.
40. The identification device according to claim 26 as a component
of a dialysis machine for conducting a dialysis treatment on a
patient, having the dialyzer apparatus and the sensor device.
41. The identification device according to claim 40, further
comprising a housing holder configured separately from the dialyzer
apparatus or connected in a fixed manner to the dialysis machine,
wherein the housing holder is designed to fix the dialyzer
apparatus in a removable fashion.
42. The identification device according to claim 41, wherein the
sensor device is integrated into the housing holder.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is the U.S. national phase application of
PCT International Application No. PCT/EP2014/056214 filed Mar. 27,
2014, which claims priority to German Patent Application No. DE 10
2013 103 336.9 filed Apr. 3, 2013, the contents of each application
being incorporated by reference herein.
FIELD OF THE INVENTION
[0002] The invention relates, inter alia, to a device for
identifying a dialyzer apparatus or a component thereof such as,
for example, a membrane filter device of the dialyzer apparatus
before or during the operation of the dialyzer apparatus, for
example, treating a patient's blood. The invention further relates
to a sensor device for detecting a state of a dialyzer and,
optionally, for identifying a dialyzer, also referred to below as a
dialyzer apparatus, or a component thereof such as, for example, a
membrane filter device of the dialyzer apparatus; a dialyzer
apparatus that is designed for detecting or measuring such
information with such a sensor device; a system comprising such a
sensor device and such a dialyzer apparatus; as well as a dialysis
machine having such a sensor device and such a dialyzer
apparatus.
BACKGROUND
[0003] FIG. 1 shows a dialysis machine 300 for performing the
hemodialysis treatment of a patient 10 in a dialysis operation.
Alternatively or additionally, the dialysis machine 300 may also be
designed to perform hemofiltration or hemodiafiltration and may
also comprise a dialysate flow path or a dialysate fluid circuit
40, hereinafter also referred to as the dialysate circuit 40, a
blood flow path or blood circuit 20 located extracorporeally of the
patient 10, and a dialyzer apparatus 100 having an internal volume
portion 120 and a membrane filter device 190 located therein having
a membrane. The dialyzer apparatus 100 treats the blood of the
patient 10, for example, via a hemodialysis treatment because the
exchange of materials between the blood of the patient 10 flowing
through the blood circuit 20 and the dialysate flowing through the
dialysate circuit 40 occurs therein or in the membrane disposed
therein. Here and in the text below, the term "dialysate" is
intended to refer to the dialysate liquid and/or to the dialysate
liquid used.
[0004] The membrane of the membrane filter device 190 spatially
separates the internal volume portion 120 to form the blood region
130 through which the blood of the patient 10 flows and the
dialysate region 170 through which the dialysate flows. The
exchange of materials through the membrane includes the passage of
substances normally excreted with urine, some of them toxic,
through the membrane into the dialysate caused by a concentration
gradient in the blood of said substances and, vice versa, the
passage of substances dissolved in the prepared dialysate through
the membrane and into the blood of the patient caused by a
concentration gradient of said substances in the dialysate. The
substances contained in the prepared dialysate are added to and
dissolved in the dialysate via components 42, 44, 54 of the
dialysate preparation in a distribution of concentrations
specifically prepared for the patient 10.
[0005] Devices are known with which measurements of parameters may
be made outside of the dialyzer apparatus 100, from which
conclusions may be drawn regarding the performance, for example,
the dialysance, of the dialyzer apparatus or the clearance of the
extracorporeal blood circuit. Corresponding methods for analyzing
the parameters measured by said devices and for providing
information regarding the performance of a dialyzer apparatus are
also known.
DESCRIPTION OF THE RELATED ART
[0006] DE 32 23 051 A1 discloses a dialyzer apparatus having a
regulated dialysate composition, with the material composition of
the dialysate being determined on the basis of signals from sensors
located upstream and downstream of the dialysate region in the
dialysate circuit for the measurement of electrical conductivity.
On the basis of the device disclosed in DE 32 23 051 A1, a method
disclosed in EP 428 927 A1 may be used to determine dialysance
based on a variation in the composition of the dialysate liquid.
The numeric value obtained for the dialysance of the dialyzer using
this method is identical to that of the clearance that shows the
quantity of, for example, toxic substances, removed from the blood
per unit of time.
[0007] DE 10 2010 043 574 A1 discloses a manually opened clamp
mounting to be attached in a removable fashion to a single-use
medical article such as, for example, a line or a tube of the blood
circuit 20 or a dialyzer 100 designed as a single-use article. The
clamp mounting comprises a first clamping jaw and a second clamping
jaw hinged thereon and pivotable relative to the first clamping
jaw, between which the single-use article to be attached may be
clamped, and a sensor for detecting the relative position of the
clamping jaws. Based on the signal generated by the sensor, the
relative position of the clamping jaws and therefore the size
and/or diameter of the object clamped between the clamping jaws may
be determined. Based on this, the type of object held in the clamp
may be determined.
[0008] US 2012/0154789 A1 describes a sensor clip unit for the
optical monitoring of blood flowing through a blood chamber
connected in-line to a blood duct, in particular for the monitoring
of materials dissolved in the blood. The sensor clip unit comprises
two clamping jaws pivotable relative to one another and disposed
opposite one another relative to the blood chamber, between which
the blood chamber may be clamped. A light emitter is disposed in
the first clamping jaw and a photodetector is disposed in the
second clamping jaw. The photodetector measures the intensity of
light with wavelengths in the infrared spectral range that has
passed through the blood flowing through the blood chamber. The
wavelengths are selected in a material-specific fashion such that
the absorption of light by specific materials contained in the
flowing blood such as, for example, hematocrit or oxygen, is
measured and variations in the blood volume may be determined.
[0009] US 2012/095351 A1 discloses a device for the treatment of
blood in an extracorporeal circuit. It comprises at least one blood
pump and at least one filter unit. The device comprises at least
one pressure measuring element for detecting blood pressure, with
the pressure measuring element comprising a sensor unit and an RFID
transponder.
[0010] WO 02/34314 A1 discloses a single-use set for dialysis or
ultrafiltration treatment of blood and comprises a storage region.
This storage region contains information related to the disposable
set and/or single-use set. The data allow, for example, calibration
data to be inferred for the sensors (model, production date, and
other information).
[0011] US 2006/283801 A1 relates to a method and a device for the
preparation of liquids used in a device for extracorporeal blood
treatment and to a device for the treatment of blood using said
method and said device. In this prior art document, sensors are
used that indicate the presidents of two filters. The sensors may
transmit the properties of the filter or an identification code in,
for example, a wireless fashion.
SUMMARY OF THE INVENTION
[0012] The invention is based, inter alia, on the insight that a
contact-free measurement for the purpose of identification, for
example, of a type of dialyzer apparatus and/or a component of the
dialyzer apparatus, for example, a membrane filter device present
in the dialyzer apparatus, is advantageous. Using exemplary
embodiments of the invention, measurements may be performed or an
identification may be conducted directly on the dialyzer. This is
advantageous because the dialyzer represents the most critical part
of a dialysis machine from a therapeutic viewpoint because the
material exchange takes place in the dialyzer and the efficiency of
the dialysis is substantially influenced there. Also, for reasons
of geometry, the blood in the dialyzer is in a highly mutual
interaction with the membrane of the membrane filter device, such
that the strongest effects on the parameters relating to blood and
dialysate take place in the dialyzer. Here, it is also possible to
take into account that parameters indicative of dialysis
efficiency, for example, hematocrit and blood coagulation
properties, can also change over the time the blood is in the
dialyzer and return to their original state outside of the dialyzer
via compensation mechanisms. For example, due to the pressure
conditions in modern dialyzers that are optimized for a high flow
rate, hematocrit will initially increase and then decrease over the
length of the blood region. This trend in the hematocrit
concentrations in a dialyzer could not be directly measured up to
now even though it is known that maximum hematocrit concentration
is a decisive parameter for coagulation, clotting, and hemolytic
effects. Local concentrations and differences in concentration of
the materials dissolved in the dialysate also contain important
information regarding the quality of the hemopurification in the
dialyzer along the length of the membrane. A measurement and/or
monitoring of corresponding parameters in the exemplary embodiments
such as, for example, the coagulation state, conducted directly on
the dialyzer is therefore advantageous.
[0013] According to one aspect, the invention provides a device for
the identification of a dialyzer apparatus or a component thereof.
Here, a reusable sensor device and/or a system having a reusable
sensor device may be used that allows the most direct information
possible regarding the identification of, for example, a dialyzer
apparatus embodied as a single-use article or, for example, a
membrane filter device embodied as a single-use article of the
dialyzer apparatus to be captured directly at the dialyzer
apparatus.
[0014] According to one or more embodiments, a device for the
measurement of parameters is provided from which information
regarding the identification of a dialyzer apparatus or a membrane
filter device of the dialyzer apparatus may be obtained during its
operation in a dialysis treatment of the patient. Here, the
measurements are conducted directly at the dialyzer apparatus. The
dialyzer apparatus and/or at least the membrane filter device
placed therein is a single-use product that, as a rule, is used
only during a single dialysis treatment on one patient and is
disposed of thereafter. For this reason, it is advantageous for the
sensor device to be reusable for multiple dialyzer apparatuses.
[0015] The invention provides a device having the features of the
independent claim as well as a sensor device, a dialyzer apparatus,
and a dialysis machine.
[0016] According to a first aspect of the invention, a device is
provided for detecting or measuring information for the
identification of a dialyzer apparatus or a component such as a
membrane filter device of the dialyzer apparatus before and/or
during operation of the dialyzer apparatus in a dialysis treatment
of a patient is provided. In one or more exemplary embodiments, the
system comprises a dialyzer apparatus having a housing surrounding
an internal volume portion and a membrane filter device essentially
disposed in the internal volume portion, and a sensor device that
may be operatively connected to the housing of the dialyzer
apparatus in a detachable fashion and that comprises a signal
receiving unit that is designed to receive at least one single such
as, for example, a radiation signal, for example, from the surface
of the housing, from an identifier attached to or embodied on the
surface of the housing such as a label, or from the internal volume
portion of the housing, said signal being characteristic of the
state and/or the identification of the dialyzer apparatus and/or
the membrane filter device of the dialyzer apparatus. The sensor
device may optionally be attachable in a removable fashion to a
housing (110) of the dialyzer apparatus (100) in such a way that it
is held by the house. Alternately, the sensor device may be
designed in such a way that it is held by the housing, where it
may, for example, be integrated into the or even attached thereto.
The housing may optionally be permeable at least in some areas to a
signal, for example, a radiation signal, in order to, for example,
be able to identify materials, substances, or markings on or in the
interior of the housing. An identification of the dialyzer or
components thereof may alternatively or additionally be
accomplished with features attached to the outside of the
housing.
[0017] According to a second aspect of the invention, a sensor
device is provided that is designed to be operatively attachable to
the housing of the dialyzer apparatus in a removable fashion.
[0018] According to a third aspect of the invention, a dialyzer
apparatus, i.e., preferably a dialyzer, having a housing
surrounding an internal volume portion and the membrane filter
device essentially disposed in the internal volume portion is
provided, with the housing being permeable, impermeable, or
permeable at least in some areas to a signal such as, for example,
a radiation signal. Here, the dialyzer apparatus may be designed in
such a way that is sensor device may be operatively connected to it
in a detachable fashion.
[0019] According to a fourth aspect of the invention, a dialysis
machine is provided for conducting dialysis treatment on a patient.
The dialysis machine comprises a dialyzer apparatus according to
the third aspect of the invention and the sensor device according
to the second aspect of the invention. The sensor device may be
operatively connected or connectable to the dialyzer apparatus in a
detachable fashion.
[0020] The design of the sensor device to be operatively
connectable in a detachable fashion to the dialyzer apparatus
allows the sensor device to be used repeatedly and/or on a
plurality of dialyzer apparatuses to measure information, while the
dialyzer apparatus or parts thereof may be designed as single-use
articles.
[0021] The ability of the sensor device to directly connect to the
dialyzer apparatus, i.e., to the dialyzer, allows the measurement
of information to be conducted directly at the dialyzer apparatus
and thus for the desired information to be measured in the most
direct and/or detailed manner possible.
[0022] The sensor device according to aspects of the invention
allows the identification of the dialyzer apparatus or the
component, for example, the membrane filter device of the dialyzer
apparatus, to be conducted in a direct, error-free, and reliable
fashion and for information regarding the state of the dialyzer
apparatus, in particular the state of the component, for example,
the membrane filter device, to be measured in a precise, detailed,
and direct fashion at the dialyzer apparatus and/or the component,
for example, the membrane filter device. Such information may
include parameters that are indicative of the efficiency of the
material exchange for the membrane of the membrane filter device,
particularly including dialysance. The efficiency of the material
exchange is a function of the material composition of the prepared
dialysate, the material composition, in particular the
concentration of materials contained in the patient's blood to be
removed from the patient's blood via dialysis treatment, and of
processes in the dialyzer apparatus, in particular on the capillary
level and/or in the pores of the membrane of the membrane filter
device, such as, for example, a localized clog in the membrane due
to, for example, clotting in the filter. The signal to be measured
may be selected in such a way that it is indicative of at least one
of these values. This allows the possibility of a space-resolved
measurement of parameters in the dialyzer. This measurement may
occur simultaneously or sequentially at two or more points on or in
the dialyzer, for example, along the dialyzer in its axial
direction, along its circumference, or also obliquely thereto, for
example, along one or more lines, or at locations distributed in
any other desired fashion, or even at multiple sequential measuring
points located at least partially in the radial direction of the
dialyzer.
[0023] The device according to aspects of the invention may be
designed to provide the measured signal to an analysis unit that,
based on the measured signal, identifies or at least is able to
identify the dialyzer apparatus and, optionally, additionally
generates data that can be used to control operating parameters of
a dialysis machine.
[0024] The signal receiving unit may be designed to detect
radiation signals of any kind or even selected from a group
including, for example, the following: a) electromagnetic radiation
with any desired wavelength, for example, in the optical range such
as far infrared (FIR), infrared (IR), near infrared, visible, and
ultraviolet (UV) light, b) electromagnetic radiation having a
wavelength or a wavelength range or the corresponding frequency
range from the entire electromagnetic spectrum such as, for
example, in the microwave range, in the terahertz range, i.e., in
the submillimeter range, or in the range of radio waves, such as
radio waves used in RFID technology, and c) ultrasound waves. The
wide range of options for the signal receiving unit allows
different information and/or types of information and/or various
parameters of the dialyzer apparatus or the membrane filter device
to be measured.
[0025] The signal receiving unit may comprise a receiver for a
magnetic, electrical, or electromagnetic signal, said signal being
indicative of a capacity to be measured and/or an inductivity to be
measured that is characteristic of the state and/or the
identification of the dialyzer apparatus and/or the membrane filter
device. Such signal may, for example, be detected in a reliable and
error-free manner from the exterior region or even from the edge or
internal volume portion of the dialyzer apparatus by the receiver
located, for example, on or outside the dialyzer apparatus.
[0026] The sensor device according to the second aspect of the
invention may comprise a radiation transmitting unit that is
designed to emit radiation, in particular radiation from the entire
electromagnetic spectrum such as, for example, radiation with a
wavelength or a wavelength range or the corresponding frequency
range from the entire electromagnetic spectrum such as, for
example, microwave range, terahertz range, i.e., in the
submillimeter range, or in the range of radio waves such as, for
example, radio waves used in RFID technology, or optical radiation,
or ultrasound radiation, onto the housing or even into the internal
volume portion of the housing of the dialyzer apparatus.
Correspondingly, the signal receiving unit may be designed to
measure the intensity of radiation emitted by the radiation
transmitting unit. Thus, in operation, the measured radiation may
be the result of an interaction characteristic of the state of the
dialyzer apparatus that has taken place in the internal volume
portion of the housing between the radiation and one or more of the
following: the dialysate and/or the blood, a substance contained in
the dialysate and/or the blood, the membrane filter device and a
substance held in and/or on the membrane filter device that or
originates from the blood and/or the dialysate. Thus, at least part
of the measured radiation from the internal volume portion is able
to arrive at the signal receiving unit. In particular, the
interaction can be triggered by the radiation emitted into the
internal volume portion by the radiation transmitting unit. The
measurement of a result of an electromagnetic, for example,
optical, interaction of, for example, radiation emitted into the
internal volume portion, allows for the touch-free measurement of
the above-mentioned elements, for example, present in the internal
volume portion during operation and thus the measurement of
parameters directly characterizing the state of the dialyzer
apparatus. In measuring radiation originating, for example, from
the surface or from the interior of the dialyzer and received as a
reflection, diffusion, diffraction, or frequency conversion of
electromagnetic radiation such as light that is diffuse or emitted
in a targeted fashion, it is possible for a space-resolved
measurement to be conducted in one, multiple, or all exemplary
embodiments. Space-resolved measurements allow, for example, the
space-resolved determination of dialyzer-specific properties. The
use of spatial resolution as a measurement principle allows, for
example, influences such as diffraction or deflection of an
incident light beam to be determined and parameters to be derived
therefrom. For spatial resolution, for example, measurements may be
taken at one or more positions such that dialyzer-specific
properties may be measured in a space-resolved fashion. Here, the
plurality of measurements may be combined with one another in order
to increase measurement accuracy. To this end, the measured
radiation may be detected at multiple points in the direction of
the beam path, or transversely or obliquely thereto, by one or more
sensors. Thus, spatial resolution results as a measurement
principle, for example, for determining the diffraction of an
incident electromagnetic ray, such as light, and for driving
parameters therefrom, for example, regarding the index of
refraction, the internal structure, the material of the dialyzer,
or the like.
[0027] An electromagnetic, for example, optical, interaction may be
triggered that is selected, for example, from a group comprising
following: [0028] reflection of radiation on the surface of the
housing or reflection of electromagnetic, for example, optical,
radiation emitted by the radiation transmitting unit on a boundary
surface between the housing wall, for example, the window region,
and the dialysate or the blood, [0029] reflection of radiation
emitted by the radiation transmitting unit on a boundary surface
between the membrane filter device and the dialysate or the blood,
[0030] transmission of radiation emitted by the radiation
transmitting unit having a measuring wavelength that can be
absorbed by a substance contained in the dialysate and/or in the
blood and that, on its way to the radiation receiving unit, has
followed a beam path through the dialysate and/or through the
blood, [0031] emission of luminescent or fluorescent radiation by a
material contained in the dialysate and/or in the blood, with a
luminescent or fluorescent reaction in said material being
triggered by the radiation emitted by the radiation transmitting
unit, [0032] refraction of the radiation emitted by the radiation
transmitting unit onto a boundary surface between the housing wall,
for example, a window region, and the dialysate or the blood, with
the transmitted radiation striking the boundary surface at an angle
of incidence between 0.degree. and 90.degree., [0033] scattering of
the radiation emitted by the radiation transmitting unit on a
substance contained in the dialysate or in the blood, including
dynamic scattering of monochromatic laser radiation, [0034]
interaction of the radiation emitted by the radiation transmitting
unit with an identification unit attached to the dialyzer apparatus
or the membrane filter device such as, for example, a barcode, an
RFID code, or a color code field that comprises an identifying
feature characteristic for the identification of the dialyzer
apparatus, a component thereof, a medium present in or flowing
through the dialyzer apparatus, or the membrane filter device. Any
codes may be used for this purpose such as, for example, optical,
acoustic, electrical, magnetic, and other codes, including a
mechanical form of encoding, for example, a special housing shape
that is simultaneously an optical element, or text recognition,
[0035] RFID.
[0036] The highly versatile selection possibilities of the optical
interaction that the measured radiation in the internal volume
portion has with the elements located therein allows different
information or types of information or various parameters for the
identification of the dialyzer or for detecting elements present in
the internal volume portion or the membrane filter device to be
measured.
[0037] In one exemplary embodiment, multiple exemplary embodiments,
or all exemplary embodiments, the dialyzer apparatus or the
component, for example, the housing, a cover, or the membrane
filter device, comprise a so-called passive identification unit
comprising an identification feature that is characteristic for the
identification of the dialyzer apparatus or the component, for
example, the membrane filter device, that may be read, for example,
by illuminating the identification unit with a predetermined
electromagnetic radiation. Here, the sensor device may comprise a
radiation transmitting unit that is designed to emit the
predetermined electromagnetic radiation, in particular onto the
identification unit. Here, the signal receiving unit may comprise
an identification reader unit that is designed to detect a
parameter of the radiation that is indicative of the identifying
feature and to determine the identifying feature. In this
embodiment, the identification unit may be, for example, a barcode,
a color code field, or a passive RFID chip. The identification unit
allows information regarding the identification of the dialyzer
apparatus or the membrane filter device to be measured in a
particularly reliable, direct, and essentially error- and
malfunction-free manner.
[0038] Alternatively, the dialyzer apparatus or the membrane filter
device may comprise a so-called active identification unit that is
able to transmit electromagnetic radiation having an identifying
feature that is characteristic for the identification of the
dialyzer apparatus or the membrane filter device. In such a case,
the signal receiving unit may comprise an identification reader
unit that is designed to detect the electromagnetic radiation
emitted by the identification unit and to determine the identifying
feature, for example, after a demodulation analysis. Such an
identification unit may, for example, be an active RFID chip. In
this embodiment with an active identification unit, it is also
possible for information regarding the identification of the
dialyzer apparatus or the membrane filter device to be measured in
a particularly reliable, direct, and essentially error- and
malfunction-free manner.
[0039] The radiation transmitting unit may comprise at least one or
more of the following features: a light source that emits light in
a narrow-band spectral range, such as a laser or an LED, a light
conductor that guides light emitted by a light source emitting
light in a narrow-band spectral range, and an uncoupling section
from which the light exits, a light source that emits light in a
wide-band spectral range, such as a halogen lamp, or a light
conductor that guides light emitted by a light source emitting
light in a wide-band spectral range, and an uncoupling section from
which the light exits. This broad range of configuration options
for the radiation transmitting unit allows for different types of
optical interactions to be induced of the radiation transmitted
into the internal volume portion with the elements present therein
and, as a result, for different parameters and/or data regarding
the status of the dialyzer apparatus and/or the membrane filter
device to be measurable.
[0040] The radiation transmitting unit may comprise a
one-dimensional arrangement or a two-dimensional arrangement of
multiple radiation emission areas. The radiation transmitting unit
may comprise one or more transmitters or emitters and, optionally,
light conductors as well. In one or more exemplary embodiments, the
housing itself may serve as a light conductor. An excellent
alignment, i.e., a preferred, for example, a linear alignment, of
the one-dimensional or two-dimensional arrangement in operation and
in the connected state of the sensor device and the dialyzer
apparatus essentially parallel to a flow direction of the dialysate
in the dialysate region, or parallel to the flow direction of the
blood in the blood region, or parallel to a longitudinal axis of
the dialyzer apparatus, or along the circumference of the housing,
or transverse or oblique to these alignments, or combined two or
more of these alignments, i.e., distributed in a two-dimensional or
three-dimensional fashion, may be aligned. The structure of the
radiation transmitting unit with a one- or two-dimensional
arrangement of a plurality of light-emitting regions allows the
emitted light to be spatially distributed and to be emitted into
the internal volume portion of the dialyzer apparatus in a
spatially selectively distributed fashion and, as a result, for
example, in the case of a suitable design of the radiation
measurement unit, allows the desired information to be measured in
a spatially selective fashion.
[0041] The sensor device may comprise a radiation measurement unit,
for example, having a radiation influencing unit such as an optical
measuring unit, and a radiation detector, for example, a light
detector, having a radiation- or light-sensitive detector surface.
The functionality of the radiation influencing unit may also be
provided by the housing itself. The housing may, for example, be
equipped with one or more light conductors.
[0042] The radiation influencing unit or optical measuring unit may
optionally have a focal depth and/or a focal direction. The
radiation influencing unit may also be designed to project or focus
radiation or light from the light source at a certain point in the
dialyzer. Alternatively or additionally, the radiation influencing
unit may be used to focus light from the dialyzer onto the sensor
device (detector) and not only to project it. Here, the radiation
influencing unit may be designed, like the optical measuring unit,
to project a spatial region from the internal volume portion of the
housing of the dialyzer apparatus onto the detector surface of the
light detector, said spatial region being defined by the focal
depth and focal direction. The radiation influencing unit may be
designed in such a way that its focal depth and focal direction may
be selected so as to select the projected spatial region in the
area of the internal volume portion. By this design of the
radiation measurement unit, the desired information may be measured
in a spatially selective fashion on the outer or edge region or, in
some cases, from or in the internal volume portion, for example, to
identify the dialyzer.
[0043] The sensor device may comprise a radiation measurement unit
having at least one radiation inlet region and at least one
radiation detector, for example, a light detector, that is designed
to detect radiation, such as light, that has entered the at least
one radiation inlet region and that is selected, for example, from
a group that may include the following: a photodiode, a
phototransistor, a CMOS light detector, a photomultiplier having
one or more multiplier elements disposed one dimensionally in a
linear fashion or distributed in a flat two-dimensional fashion, an
avalanche photodiode having one or more of photodiode elements
disposed one-dimensionally in a linear fashion or distributed in a
flat two-dimensional fashion, a one-dimensional or two-dimensional
CCD sensor, and a one-dimensional arrangement or a two-dimensional
arrangement of a plurality of photodiodes, phototransistors, CMOS
light detectors, photomultipliers, or avalanche photodiodes, or
other detectors such as MPPCs (multi-photon pixel counters), or
other sensor elements. The multitude of options for selecting the
type of radiation detector allows optimally suitable radiation
detectors to be provided in each case for the measurement of
different parameters and/or information.
[0044] A given radiation inlet region may comprise a coupling-in
region for an optical light guide or a light-conducting fiber that
is designed to direct the radiation to a light detector associated
with the radiation inlet region. This design allows the radiation
inlet region and the light detector associated therewith to be
located at a spatial distance from one another and/or to be
spatially decoupled. Thus, light detectors may optionally also be
used that occupy a relatively large amount of space to measure
light that is "captured" at the radiation inlet region directly on
the dialyzer apparatus.
[0045] The sensor device may comprise a radiation measurement unit
having at least one light detector and a wavelength selection unit
such as, for example, a monochromator, with the wavelength
selection unit being designed to select a narrow-band wavelength
range that includes a reference wavelength from, for example, a
wider-band wavelength range of the radiation emitted by the
radiation transmitting device, for example, light, in such a way
that an optical interaction such as absorption or excitation of
luminescent or fluorescent emissions, occurs with a selected
material that is located in the internal volume portion of the
housing during operation. This material may be, for example, a
component of the dialysate and/or the blood. The
wavelength-selective measurement of radiation, for example, light,
allowed by this design also allows material-specific
measurement.
[0046] The sensor device may be designed to detect at least one or
more of the following parameters or values: [0047] measuring for a
parameter indicative of the concentration of a uremic toxin in the
blood region of the internal volume portion, such as the absorption
of light, having a measured wavelength that is absorbed by the
uremic toxin; [0048] in the dialysate region of the internal volume
portion, measuring for a parameter indicative of the concentration
of a uremic toxin such as the absorption of light having a measured
wavelength that is absorbed by the uremic toxin; and [0049] in the
blood region, measurement of a parameter that is indicative of a
physical property of the blood such as, for example, viscosity or
hematocrit concentration.
[0050] The possibility of designing the sensor device for the
varied tasks listed above allows for parameters to be measured that
are frequently used in practice and/or characterize the progress of
dialysis therapy on the patient. Correspondingly, on the basis of
the measurement of these parameters, the settings and/or operating
parameters of a dialysis machine may be adapted over the course of
dialysis therapy to the progression of the dialysis therapy.
[0051] The housing of the dialyzer apparatus according to the third
aspect of the invention may be designed in such a way that the
sensor device may be detachably fixed in one or more predetermined
positions relative to the housing with a positive fit. In an
advantageous embodiment, the housing may comprise coupling regions
on its exterior in one or more positions and the sensor device may
comprise a second coupling region that is designed to engage with
the first coupling region in a positive fit, for example, such that
it may be pressed on. The attachment of the sensor device at a
predetermined position relative to the housing allows one sensor
device to be used with various dialyzer apparatuses to measure the
desired information in a reliable fashion under comparable
measuring conditions, thus measuring in a comparable fashion.
[0052] The sensor device according to the second aspect of the
invention is preferably designed in a reusable fashion. Due to this
reusability, it becomes efficient and cost-effective to use even
relatively elaborate, complex, and therefore expensive sensor
equipment.
[0053] The design of the sensor device according to be attachable
to or on the housing of the dialyzer apparatus in a detachable
fashion, particularly in a detachable fashion with a positive fit,
may, for example, be achieved using at least one of the following
mechanisms: [0054] the sensor device is designed as a clip device
having at least one or more clip cuffs, said clip cuffs being
designed to encompass the housing in an angular range of more than
180.degree., preferably more than 270.degree., and even more
preferably more than 320.degree., [0055] the sensor device
comprises a base body and a clip unit having at least one arm or,
for example, two or more arms such as a pair of clip arms attached
to the base body in an elastically flexible fashion, for example,
in an articulated fashion, designed to encompass the housing
between themselves and, due to their flexible elastic design or
articulation, encompass the housing in the manner of a clip, the
sensor device comprises a first member of a connector unit, such
as, for example, a dovetail unit, a screw and/or a Velcro fastener,
and the dialyzer unit comprises a second member of the connector
unit such as, for example, a dovetail mount, a bore or screw thread
for screwing in the screw and/or the matching piece to the Velcro
fastener, with the first member being designed to engage in a
positive fashion with the second member or with the second member
being designed to engage in a positive fashion with the first
member, and with both parts of the Velcro fastener and/or the other
connector units also both being attachable to the "clip," which
then fixes the dialyzer apparatus in place by correspondingly
tightening the connector unit, [0056] the sensor device is clamped
into place on the housing with an elastic clamping unit, such as a
rubber ring, with the clamping unit being designed to encompass the
sensor device and the housing of the dialyzer apparatus in an
elastically tense state, [0057] the sensor device comprises a base
body and at least one pair of arms and/or cuffs articulated on the
base body or attached to the base body in an elastically flexible
fashion, each of which comprises a distal end region having a first
member of a hook or engaging unit, with the arms and/or cuffs being
designed to encompass the housing in an angular range of more than
180.degree., preferably more than 270.degree., and more preferably
more than 320.degree., and an elastically tensible clamping unit
having two end sections located opposite one another on each of
which a second hook or engaging unit is provided that is designed
to engage in a detachable fashion with a first member of the hook
or engaging unit, with each second member on the end section of the
clamping unit being able to engage with a first member on the end
region of the arms and/or cuffs of the sensor device when the
clamping unit is in an elastically tense state, and [0058] the
sensor device is designed to be integrated in a detachable fashion
into the wall of the housing of the dialyzer apparatus, for
example, in a recess.
[0059] The housing of the dialyzer apparatus may comprise a housing
wall having at least one window region that is permeable for a
signal. The design with a window region that is particularly
permeable to a signal allows for precise measurements of the
desired information and/or parameters to be conducted using the
sensor device to be attached on or in the vicinity of the window
region, even in the case of a housing whose housing wall may
otherwise be made of a material that is less permeable to the
signal, for example, for reasons of cost.
[0060] The housing wall may essentially be designed in the shape of
the cylinder. This design allows the sensor device to be easily
attached in various positions along a longitudinal direction of the
housing wall and with lines of sight that vary azimuthally relative
to the longitudinal axis.
[0061] In a first embodiment, the membrane filter device may be
incorporated into the housing of the dilator device in a removable
fashion. This embodiment allows for only the membrane filter device
to be designed as a single-use article, while the housing of the
dialyzer apparatus, in particular, for example, if relatively
expensive window regions are integrated therein, may be
reusable.
[0062] In a second, alternate embodiment, the dialyzer apparatus
may additionally comprise another inner housing that may be fixed
in the housing in a removable fashion and that essentially
encompasses the membrane filter device. Here, the inner housing, in
particular with the membrane filter device disposed therein, may be
inserted in the housing of the dialyzer apparatus in a removable
fashion. This embodiment allows the inner housing with the membrane
filter device to be designed as a single-use article, while the
housing of the dialyzer apparatus, in particular, for example, if
relatively expensive window regions are integrated therein, may be
reusable.
[0063] In the first embodiment of the dialyzer apparatus, at least
the membrane filter device may be designed as a single-use article.
In the second embodiment, the inner housing and a membrane filter
device may be designed as single-use articles. In this embodiment,
in one or more exemplary embodiments, the sensor equipment may also
be directly incorporated into the dialyzer housing, with only the
electrical interfaces having exterior contact on the dialyzer.
[0064] In the first and second embodiments mentioned above, it is
preferred for the housing to be designed in such a way that it may
be easily and thoroughly cleaned.
[0065] The dialyzer apparatus as a whole may also be designed as a
single-use article. In this embodiment, it is not necessary to
clean the dialyzer apparatus or components thereof after dialysis
therapy has been performed on a patient.
[0066] The internal volume portion of the dialyzer apparatus may
comprise a dialysate region through which dialysate may flow during
operation and a blood region through which blood may flow during
operation, with the dialysate region being spatially separated from
the blood region by the membrane filter device. The membrane filter
device may be designed to allow a material exchange between the
blood and dialysate during operation driven by concentration
gradients of materials dissolved in the blood and/or in the
dialysate. These designs allow the use of the dialyzer apparatus
according to the third aspect of the invention in conventional
dialysis machines.
[0067] The dialyzer apparatus or a dialysis machine according to
the fourth aspect of the invention may comprise at least one
housing holder that is designed to be at least mechanically
connected to the dialysis machine during operation and to attach
the dialyzer apparatus to the dialysis machine in a removable
fashion. The housing holder can hold the dialysis device,
optionally with the sensor device attached to the dialyzer
apparatus in operation, in a reliable fashion.
[0068] In the dialysis machine, the sensor device may be integrated
into the housing holder. This design simplifies handling of the
sensor device because it need not be attached to the housing of the
dialyzer apparatus in an additional step.
BRIEF DESCRIPTION OF THE DRAWINGS
[0069] The invention is best understood from the following detailed
description when read in connection with the accompanying drawings.
Included in the drawings are the following figures:
[0070] FIG. 1 is a schematic depiction of a blood circuit and a
dialysis circuit, for example, disposed in a dialysis machine,
during dialysis operation, with a patient being connected to the
blood circuit as an extracorporeal blood circuit;
[0071] FIG. 2A is a schematic side view of a system having a first
embodiment of the sensor device operatively connected in a
detachable fashion to a first embodiment of a dialyzer apparatus;
FIG. 2B is a schematic top view of the system with the sensor
device and the dialyzer apparatus from the left-hand side; and FIG.
2C is a schematic cross-section along the line A-A through the
system with the sensor device and the dialyzer apparatus from the
left-hand region;
[0072] FIG. 3A is a schematic side view of the system having a
second embodiment of a sensor device operatively connected in a
detachable fashion to a second embodiment of the dialyzer
apparatus; FIG. 3B is a schematic cross-section along the line A-A
through the system with the sensor device and the dialyzer
apparatus from the left-hand region; and FIG. 3C is a schematic
depiction of the sensor device from the left-hand region in a
rolled-apart state; and
[0073] FIG. 4 is a block diagram of a dialysis machine and its
functional components, including an embodiment of a system having
an embodiment of the sensor device that is detachably connected to
an embodiment of a dialyzer apparatus.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0074] FIG. 1 schematically shows a dialysis machine 300 for
conducting a hemodialysis treatment of a patient 10. As already
mentioned at the outset, the dialysis machine 300 comprises the
dialysate circuit 40, the blood circuit 20, which is extracorporeal
to the patient 10, and a dialyzer, i.e., the dialyzer apparatus 100
having the internal volume portion 120 and the membrane filter
device 190 disposed therein with the membrane at which the material
exchange occurs between the blood of the patient 10 passing through
the blood circuit 20 and the dialysate passing through the
dialysate circuit 40.
[0075] The dialysate circuit 40 may be essentially disposed inside
the dialysis machine 300 but may also be structured differently,
and comprises in detail components 42, 44, 54, 60 for processing
the dialysate, the dialysate region 170 of the dialyzer apparatus
100, a dialyzer entry valve 72, and the dialysate inlet 74 for
allowing the prepared dialysate to enter the dialysate region 170,
a dialysate outlet 76, and a dialyzer exit valve 78 for allowing
the used dialysate to exit the dialysate region 170 and for
removing the dialysate to the elements 84, 80, and 86 of the
dialysate exit. The components of the dialysate preparation
typically comprise a water preparation unit 42 for providing a
stream of prepared water into the dialysate supply lines 62, 62', a
bicarbonate concentrate provided in a reservoir 44 that is dosed
into the dialyzer supply line 62 in a metered amount via the
bicarbonate inlet 48 with a controllable bicarbonate pump 46, an
acid concentrate provided in a reservoir 54 that is dosed into the
dialyzer supply line 62 in a metered amount via the acid inlet 58
with a metered acid pump 56, and an in-line balancing unit 60
located downstream of the inlets 48, 58 in the dialyzer supply line
62. The balancing unit 60 or a control unit contained therein or
connected thereto is designed to control the composition and
released amount, i.e., the dialysate flow, in a manner customized
for the patient 10 and specific to the progression of the dialysis
treatment, and in particular to generate the necessary control
signals for the bicarbonate pump 46, the acid pump 56, a flow pump
64 disposed downstream of the balancing unit 60 in the dialysate
supply line 62' for the dialysate supply, and a flow pump 84
disposed downstream of the dialysate region 170 in the dialysate
outflow line 82, 82', and to control the flow pump 64 for the
dialysate supply and the flow pump 84 for the dialysate
outflow.
[0076] The dialysate metered by the flow pump 64 and prepared
upstream thereof flows through the dialyzer inlet valve 72 and the
dialyzer inlet 74 into the dialysate region 170 of the dialyzer
apparatus 100. After undergoing the material exchange with the
blood of the patient 10 through the membrane of the membrane filter
device 190, the dialysate flows on through the dialysate outlet 76
and is supplied to the dialysate outflow or removal system 84, 80,
86 via the dialyzer exit valve 78. The dialysate removal system
comprises a balancing unit 80 typically disposed downstream of the
dialysate outflow flow pump 84 in the dialysate outflow line 82,
82' and a dialysate removal 86 disposed downstream of the balancing
unit 80 in the dialysate outflow line 82'. The dialysate removal 86
may be embodied, for example, as a collecting vessel that may be
removed or disposed of. In many cases, however, the used dialysate
may also flow directly into the drain and thus into a reprocessing
segment or into the wastewater drainage system. The dialysate
circuit 40 moreover comprises a bypass line 48 to the dialysate
region 170 of the dialyzer apparatus 100. The bypass line 48 may be
opened and closed with a bypass valve 66 and allows dialysate to
bypass the dialysate region 170 and move from the dialysate inlet
64 directly to the dialysate outflow 84.
[0077] In detail, the extracorporeal blood circuit 20 comprises an
arterial tube system 24, a blood region 130 of the dialyzer
apparatus 100, and a venous tube system 34. During a hemodialysis
treatment, the extracorporeal blood circuit 20 is installed by
specialized medical personnel and comprises an arterial tube system
24 for conveying blood to be purified from the patient 10, the
blood region 130 of the dialyzer apparatus 100, and a venous tube
system 34 for conducting purified blood back to the patient 10. The
arterial tube system 24 comprises an arterial access 22 to the
arterial blood vessel system of the patient 10 that may be set up,
for example, as an arterial needle or catheter, and an arterial
blood pump 26 for pumping the arterial blood of the patient 10 from
the arterial access 22, through the blood inlet 28, and into the
blood region 130 of the dialyzer apparatus 100 and, further,
through the venous tube system 34 to a venous access 36 in the
venous blood vessel system of the patient 10. This arterial blood
pump 26 may be connected via tube to or disposed on, for example,
the arterial tube system 24. The venous tube system 34 conducts
blood purified and/or treated in the dialysate region 130 from the
blood outlet 32 of the dialysate region 130 back to the venous
access 36 of the patient 10. This closes the extracorporeal blood
circuit 20.
[0078] As already discussed above, in the schematic depiction of
the dialysate circuit 40 and the blood circuit 20 shown in FIG. 1,
the exchange of materials is occurring between the dialysate and
the blood of the patient 10 in the dialyzer and/or in the dialyzer
apparatus 100 according to the third aspect of the invention, more
precisely, on the membrane of the membrane filter device 190
located therein. The latter component divides the internal volume
portion 120 of the housing 110 of the dialyzer apparatus 100 into a
dialysate region 170 through which the dialysate flows that is
conveyed via the dialysate inlet 74 and removed via the dialysate
outlet 76, and the blood region 130 through which the blood of the
patient 10 to be treated and/or purified flows in through the blood
inlet 28 and out through the blood outlet 32 and is conveyed back
to the patient 10. The dialyzer apparatus 100 and/or a component
disposed thereon or therein, for example, the membrane filter
device 190 disposed therein, comprises a passive or active
identification unit 192 that comprises an identification feature
that is characteristic for the identification of the dialyzer
apparatus 100 and/or a component thereof, for example, the membrane
filter device 190.
[0079] In one embodiment of the device according to aspects of the
invention, the passive identification unit 192 is a passive RFID
(radio frequency identification) chip, the identifying feature of
which may be read by irradiating it with a predetermined
electromagnetic radiation, the frequency of which lies, for
example, in the RF (radio frequency) range. In another embodiment,
the passive identification unit 192 comprises a code such as, for
example, a barcode or a color code field, with the identifying
feature being readable by irradiating it with electromagnetic
radiation in the optical range having a wavelength in the infrared
(IR), near infrared, visible, or ultraviolet (UV) light range.
[0080] The dialyzer apparatus 100 shown in FIG. 1 has an exemplary
embodiment of the invention with, or in the form of, a sensor
device 200 operatively attached to the dialyzer in a removable
fashion. The sensor device 200 comprises a signal receiving unit
210 that is designed to receive at least one signal such as, for
example, a radiation signal or an ultrasound signal, from the
exterior or edge region or even from the internal volume portion
120 of the housing 110 of the dialyzer apparatus 100 and may also
be attached externally on the housing or designed as a component of
the housing. The received signal is characteristic of the state
and/or the identification of the dialyzer apparatus 100 and/or the
membrane filter 190 disposed therein. In one embodiment, the signal
receiving device 210 comprises an identification reading unit 212
that is designed to detect a parameter of the radiation that is
indicative of the identifying feature of the identification unit
192 and, in addition, to determine the identification of the
dialyzer apparatus 100 and/or the membrane filter device 190. In
order to allow the signal to reach from the internal volume portion
120 of the housing 110 to the signal receiving unit 210 disposed
outside the housing 110, the housing 110 is essentially permeable
to the signal at least in regions, or as a whole.
[0081] In order to irradiate the passive identification unit 192,
the sensor device 200 comprises a radiation emitting unit 240 that
is designed to emit the predetermined radiation, for example,
electromagnetic radiation or ultrasound radiation, in order to
contact the passive identification unit 192 so as to activate it to
transmit modified electromagnetic or ultrasound-acoustic radiation
containing the identifying feature and/or a parameter indicative
thereof.
[0082] In an embodiment with a passive RFID chip as the passive
identification unit 192, the radiation transmitting unit 240
comprises an RF radiation source (not shown). In the embodiment in
which the passive identification unit 192 is a code such as, for
example, a barcode, a data matrix, a general two-dimensional or
three-dimensional code, for example, a colored 2-D code or a color
code field, the radiation transmitting unit 240 comprises, for
example, an optical or acoustical radiation source for contacting
the code, and the identification unit 212 of the signal receiving
unit 210 comprises, for example, a code scanner for reading the
code such as a barcode scanner for reading the barcode or a camera,
for example, with a two-dimensional CCD sensor or a 2-D code reader
designed to detect the radiation, for example, optical light,
reflected by the code, for example, the barcode or color code
field, to analyze said radiation, and to recognize the indicative
parameter and/or the identifying feature contained in the detected
radiation.
[0083] In another embodiment, the dialyzer apparatus 100 or the
membrane filter device 190 comprises an active identification unit
192 such as, for example, an active RFID chip, that is able to
transmit electromagnetic radiation comprising an identifying
feature that is characteristic for the identification of the
dialyzer apparatus 100 or the membrane filter device 190. In this
case, it is not necessary for a radiation transmitting unit for
contacting the identification unit with a predetermined
electromagnetic radiation to be provided in the sensor device 200.
As is the case in the embodiments with a passive identification
unit 192, the signal receiving unit 210 comprises an identification
reading unit 212 that is designed to detect the electromagnetic
radiation transmitted by the (in this case active) identification
unit 192, for example, the active RFID chip, and, for example,
after a demodulation analysis, recognize the identifying
feature.
[0084] In another embodiment, the signal receiving unit 210
comprises a receiver for an electrical signal that is indicative of
a capacity to be measured and/or an inductivity to be measured that
is characteristic of the state and/or the identification of the
dialyzer apparatus 100 and/or the membrane filter unit 190.
[0085] In another embodiment, the signal receiving unit 210 may be
designed to receive signals from ultrasound radiation originating
from the internal volume portion 120. The ultrasound radiation may
be projected into the internal volume portion 120 and reflected in
the dialysate region 170 and/or in the blood region 130 or may pass
through these regions. In this embodiment, the signal transmitting
unit 240 comprises an emitter for emitting ultrasound radiation
onto the housing or into the internal volume portion 120, for
example, focused in the dialysate region 170 or in the blood region
130 or in the region of the membrane of the membrane filter device
190. Ultrasound radiation influenced in the internal volume portion
120 by materials dissolved in fluid (dialysate and/or blood)
located therein and/or by the membrane of the membrane filter
device 190 may be arranged in a reflection arrangement, a
transmission arrangement, or a scattering arrangement of the signal
receiving unit 210 designed for the detection of ultrasound
radiation relative to the signal transmitting unit 240 transmitting
the ultrasound radiation.
[0086] In a reflection arrangement, the direction of the radiation
to be detected--here, for example, ultrasound radiation--is
directed essentially opposite, for example, at an angle of
180.degree. or virtually 180.degree., the direction of the incoming
radiation. The reflection may also occur at an angle other than
180.degree. to the direction of the incoming radiation, i.e., for
example, in an oblique direction or perpendicular direction. In a
transmission arrangement, the direction of the radiation to be
detected is directed essentially parallel, i.e., at an angle of
0.degree. or virtually 0.degree., to the direction of the incoming
radiation. In the case of a scattering arrangement, the direction
of the radiation to be detected is directed at an angle essentially
different from 0.degree. or 180.degree., for example, 90.degree..
The terminology used here for ultrasound radiation (reflection,
transmission, and scattering arrangements) discussing radiation to
be measured relative to the incoming radiation is used herein for
optical electromagnetic radiation as well.
[0087] If the housing wall 110 is permeable at least in regions to
optical electromagnetic radiation, i.e., in this instance to
infrared (IR), near infrared, visible, or ultraviolet (UV) light
radiation, then the sensor device 200 according to exemplary
embodiment of the invention shown may also be used to conduct
optical measurements of various kinds directly on the dialyzer
apparatus 100, from which information may be obtained for the
identification of the dialyzer and/or regarding the state or a
property thereof, for example, a material concentration in the
dialysate or blood or a value derived therefrom, or the speed in
the fibers of the dialyzer apparatus, or the Brownian motion, or
the dialysance of the dialyzer apparatus 100 or the membrane filter
device 190. Optical measurements of this kind may be conducted in a
reflection, transmission, and scattering arrangement, and moreover
also in a refraction arrangement of a signal receiving unit 210
designed for the measurement of a light intensity with regard to an
optical radiation transmitting unit 240. In one embodiment, the
signal receiving unit 210 comprises an optical radiation measuring
unit 220 and a second optical radiation detector 240 (see FIG.
2).
[0088] The sensor device 200 in the exemplary embodiment shown here
may comprise a radiation transmitting unit 240 that is designed to
transmit radiation, such as optical radiation (i.e., light) or
ultrasound radiation into the internal volume portion 120 of the
housing 110 of the dialyzer apparatus 100. Correspondingly, the
signal receiving unit 210 may be designed to measure the intensity
of electromagnetic radiation or ultrasound radiation exiting the
internal volume portion 120 that was emitted by the radiation
transmitting unit 240 into the internal volume portion 120. The
radiation measured by the signal receiving unit 210 may be the
result of an interaction of the emitted radiation characteristic of
the state of the dialyzer apparatus 100 occurring in the internal
volume portion 120 of the housing 110 between the radiation and one
or more of the following objects: the dialysate in the dialysate
region 170, the blood in the blood region 130, a material contained
in the dialysate and/or in the blood, the membrane filter device
190, and a material held in or on the membrane filter device 190
that, for example, originated from the blood and/or the dialysate.
Here, the interaction has been triggered by the radiation
transmitted by the radiation transmitting unit 214 into the
internal volume portion 120 of the housing 110 and the portion of
this radiation arrives after the interaction at the signal
receiving unit 210 from the internal volume portion 120.
[0089] An optical interaction providing characteristic information
for the state of the dialyzer apparatus 100 and/or the blood in the
blood region 130 and/or the dialysate in the dialysate region 170
may be one of the following: [0090] reflection of optical radiation
(i.e., light) emitted by the radiation transmitting unit 240 onto a
boundary surface between the wall 112 of the housing 110, for
example, a window region 114, 116, 118 (see FIG. 2), and the
dialysate or the blood, [0091] reflection of optical radiation
emitted by the radiation transmitting unit 240 onto a boundary
surface between the membrane filter device 190 and the dialysate or
the blood, [0092] transmission of optical radiation emitted by the
radiation transmitting unit 240 having a measurement wavelength,
for example, in the infrared spectral range, that may be absorbed
by a material contained in the dialysate and/or in the blood and
that has passed along a beam path through the dialysate and/or
through the blood on its way to the radiation receiving unit 220,
[0093] emission of luminescent or fluorescent radiation by a
material contained in the dialysate and/or in the blood, with the
corresponding luminescent or fluorescent reaction having been
provoked in said material by the optical radiation, for example, UV
light, emitted by the radiation transmitting unit 240, [0094]
refraction of optical radiation emitted by the radiation
transmitting unit 240 onto a boundary surface between the wall 112
of the housing 110, for example, a window region 114, 116, 118 (see
FIG. 2), and the dialysate or the blood, with the transmitting
radiation striking, for example, at an angle of incidence between
0.degree. and 180.degree. or between 0.degree. and 90.degree.,
[0095] scattering of optical radiation emitted by the radiation
transmitting unit 240 onto a material contained in the dialysate or
the blood, such scattering also including so-called dynamic
scattering including, for example, Raman scattering of, for
example, polychromatic or monochromatic light such as dichromatic,
polychromatic, or monochromatic laser radiation; in such a case, an
analysis may be conducted of the behavior of the scattered light
over time for the purpose of analyzing a dynamic scattering; here,
measurement is not limited to the analysis of the intensity--the
phase of the electromagnetic radiation and its behavior over time
can also contain information and be captured and analyzed instead
of or in addition to the detection of the intensity, allowing the
decay behavior of pulses over time to be analyzed as well; [0096]
interaction of optical radiation emitted by the radiation
transmitting unit 240 with a passive identification unit 192
attached to the dialyzer apparatus 100 or the membrane filter
device 190, such as a barcode field or a color code field, with the
identification unit 192 having an identifying feature that is
characteristic for the dialyzer apparatus 100 or the membrane
filter device 190. Such applications have been described above.
[0097] Now referring to FIGS. 2A-C and 3A-C, the sensor device 200
according to the exemplary embodiment shown here may be embodied as
a clip arm or clip cuff 220 that may be attached directly to the
housing 110 of the dialyzer apparatus 100 in a detachable and
operatively connectable fashion, for example, may be clipped there.
In the embodiment shown in FIGS. 2A-C and 3A-C, the sensor device
200 comprises two clip arms or clip cuffs 210, 210' that encompass
the housing 110 which is, for example, cylindrical, and that are
able to accommodate the housing therebetween.
[0098] In an embodiment as shown in FIG. 2A-C, a clip arm or clip
cuff 210 may have a shorter length relative to a length measured in
a longitudinal direction 102 of the housing 110, and may
correspondingly be shifted along the housing 110 in the
longitudinal direction 102. In this embodiment, the sensor device
200 may be used to measure a desired parameter in a definable
position along the longitudinal direction 102 of the housing 110 or
may also be used to measure the variation of a parameter along the
longitudinal direction 102 of the housing 110 with sequential
measurements at various positions along the longitudinal direction
102.
[0099] In an alternative embodiment as shown in FIGS. 3A-C, a clip
arm or a clip cuff 210 of the sensor device 200 may have a
dimension relative to the longitudinal direction 102 of the housing
110 that is comparable along the length of the housing 110 and,
correspondingly, may be designed to be only slightly slidable or
not slidable at all along the longitudinal direction 102.
[0100] In general and also particularly in the embodiments shown in
FIGS. 2A-C and 3A-C, it may be advantageous for the sensor device
200 to be able to be attached to the dialyzer apparatus 100 in one
or more repeatable or reproducible, predetermined relative
positions and/or orientations relative to said dialyzer apparatus.
To this end, the housing 110 of the dialyzer apparatus 100
comprises on its exterior surface at least one coupling region 111
or, for example, two first coupling regions 111 and 111' disposed
on the housing 110 essentially opposite one another disposed at
predetermined positions on the apparatus 100. Correspondingly, the
sensor device 200 comprises on its side facing the housing 110, for
example, in FIGS. 2A-C and 3A-C, on an interior side of the clip
arm or clip cuff 210, a second coupling region 211 or, for example,
two coupling regions 211 and 211' that, when the sensor device 200
is connected to the apparatus 100, are essentially congruent to the
coupling region or regions 111, 111' disposed on the housing 110.
In the embodiment shown in FIGS. 2A-C, a plurality of first
coupling regions 111 distributed in the longitudinal direction 102
of the housing 110, for example, at equal distances from one
another, may be provided on the outer surface of the housing 110.
These coupling regions allow the sensor device 200 to be attached
in a removable fashion at various predetermined positions along the
longitudinal direction 102 of the housing 110. The second coupling
regions 211, 211' are designed to engage and cooperate with the
first coupling regions 111, 111' such that the position of the
sensor device 200 relative to the housing 110 of the apparatus 100
is well-defined and predetermined.
[0101] In one embodiment, the first coupling regions 111, 111' and
the second coupling region 211, 211' comprise magnets that are
attracted to one another. In another embodiment, the first coupling
regions 111, 111' comprise so-called female receiving elements and
the second coupling regions 211, 211' comprise so-called male plug
elements that are designed to be received in the female receiving
elements in a removable fashion. Preferably, these female receiving
elements are assigned to the first coupling regions 111, 111' of
the housing 110 of the dialyzer apparatus 100 and the male plug
elements are assigned to the second coupling regions 211, 211' of
the clip arms and/or clip cuffs 210, 210' of the sensor device.
[0102] In one, multiple, or all exemplary embodiments, the sensor
device 200 and/or the dialyzer apparatus 100 may have a special
shape, for example, one or more notches, recesses, or protrusions
on or in the dialyzer housing that allow the clip, i.e., the sensor
device, to be attached in a centered fashion only at that
location.
[0103] Alternatively or additionally to the design described here
of the sensor device 200 being connectable to the dialyzer
apparatus 100 in a detachable and operative fashion, this may also
be achieved by the following mechanically releasable mechanisms, in
particular attachable with a positive fit: [0104] The sensor device
200 is designed as a clip unit having at least one or even two (as
shown in FIGS. 2A-C and 3A-C) or more flexible clip arms and/or
clip cuffs 210, 210' that are designed to encompass the housing 110
of the dialyzer apparatus 100 in an angular range of more than
180.degree., preferably more than 270.degree., and even more
preferably more than 320.degree.. [0105] The sensor device 200
comprises a base body (not shown) and a clip unit having at least
one pair of elastically flexible clip arms and/or clip cuffs
attached to the base body or clip arms and/or clip cuffs (not
shown) articulated on the base body in an elastically flexible
manner that are designed to accommodate the housing 110 or region
of the housing 110 between one another. Due to their elastically
flexible design or articulation, the clip arms and/or clip cuffs
are able to encompass the housing 110 or part of the housing 110 in
a clip-like fashion. [0106] The sensor device 200 comprises a first
member (not shown) of the connector unit (not shown) such as a
dovetail unit, a screw, or a Velcro strip, and the dialyzer
apparatus 100 comprises a second member and/or counter member (not
shown) of this connector unit, such as a dovetail mount, a bore or
screw thread, or an opposite piece to the Velcro strip. Here, the
first member is able to engage in the second member or the second
member is able to engage in the first member in a removable,
positive fitting fashion. [0107] The sensor device 200 is clamped
to the housing 110 with an elastic clamping unit (not shown), such
as a rubber ring. Here, the clamping unit may be designed to
encompass the sensor device 200 and the housing 110 of the dialyzer
apparatus in its elastically tense state. [0108] The sensor device
200 comprises at least one pair of arms and/or cuffs, each of which
comprises a distal end region with a first member of a hook or
engaging unit. Here, the arms and/or cuffs are designed to
encompass the housing 110 in an angular range of more than
180.degree., preferably more than 270.degree., and more preferably
more than 320.degree.. Moreover, an elastically tensible clamping
unit having two opposite end sections is provided, on each of which
a second member or counter member of the hook or engaging unit is
provided for detachably engaging a first member of the hook or
engaging unit. Here, in an elastically tense state of the clamping
unit, a respective second member on the end section of the clamping
unit can engage with a first member on the end regions of the arms
and/or cuffs of the sensor device 200, such that the arms and/or
cuffs of the sensor device 200, along with the elastically tense
clamping unit, completely surround or encompass the housing 110.
Optionally, the sensor device 200 may comprise a base body (not
shown) on which the arms and/or clamps are articulated or to which
the arms and/or clamps are connected in an elastically flexible
fashion. [0109] The sensor device 200 is designed to be integrated
in a detachable fashion, for example, into a recess in or on the
wall 112 of the housing 110 of the dialyzer apparatus 100. This
embodiment is particularly suitable when the sensor device 200 has
a spatially small expansion, such as in the case of an RF
identification reading unit 212.
[0110] In the embodiment of a device according to aspects of the
invention shown in FIGS. 2A-C having a sensor device 200, the
housing 110 of the dialyzer apparatus is not sufficiently permeable
or transparent for optical radiation (i.e., light). Therefore,
so-called window regions 114, 116, 118 are provided in the wall 112
of the housing 110 that are sufficiently permeable or transparent
for optical radiation. The radiation transmitting unit 240 is
integrated into the clip cuffs 210 that comprises a first, for
example, optical, or other kind of radiation source 242 for
emitting electromagnetic radiation, for example, light, into the
blood region 130 and a second, for example, optical, radiation
source 244 for emitting electromagnetic radiation, for example,
light, into the dialysate region 170. Moreover, a radiation
measuring unit 220 is integrated into the clip arm or clip cuffs
210, 210' having a first, for example, optical, radiation detector
designed to detect electromagnetic radiation, for example light,
exiting the blood region 130 and a second, for example, optical,
radiation detector that is designed and suitably arranged for
detecting electromagnetic radiation, for example, light, exiting
the dialysate region 170. Here, the first radiation detector 222 is
designed to measure electromagnetic radiation, for example, light,
exiting the blood region 130 that was projected in that direction
by the first radiation source 242. The second radiation detector
224 is designed to detect the electromagnetic radiation, for
example light, exiting the dialysate region 170 that was projected
in that direction by the second radiation source 244.
[0111] In one embodiment, the first radiation detector 222 is
spatially disposed or positioned relative to the first radiation
source 242 and the blood region 130 in such a way that the light
emitted by the first radiation source 242 into the blood region 130
by the second radiation detector 224 in a reflection arrangement in
which only reflected or backward dispersed light is measured. In
another embodiment, the first radiation detector 222 is disposed
relative to the first radiation source 242 and the blood region 130
in a transmission arrangement in which essentially only light is
measured that has undergone scattering in an essentially forward
direction or transmission in the direction of a well-defined path
through the blood region 130. In yet another embodiment, a
scattering arrangement is realized in which a field of view of the
first radiation detector 222 is measured relative to a primary
emitting direction of the first radiation source 242 at an angle,
preferably an angle of approximately 90.degree., but in any event
at an angle that substantially differs from 0.degree. and
180.degree.. The same statements apply for the second optical
radiation detector 224 and its arrangement or position relative to
the second radiation source 244 and the dialysate region 170.
[0112] In the embodiment of a device or a system according to
aspects of the invention shown in FIGS. 3A-C, the sensor device 200
is designed in such a way that it almost completely encompasses and
covers the housing 110, which is cylindrical in the example, of the
dialyzer apparatus 100. This is realized in the example of FIGS.
3A-C by the design of the sensor device 200 in the form of a clip
cuff 210, 210'.
[0113] In the right-hand region of FIG. 3C, the interior of the
sensor device 200 is shown that has been opened, removed from the
housing, and unrolled to be flat; this interior faces the dialyzer
apparatus 100 when the sensor device is attached to it. In the
essentially rectangular inner surface of the sensor device 200, a
plurality of radiation entrance regions 230, 232-x, 232-y, 236-x,y
and a plurality of radiation exit regions 250, 252-x, 254-y,
256-x,y are formed. For purposes of designating and defining
directions, the direction of the longitudinal axis 102 and the
direction of the circumference 104 of the housing 110 of the
dialyzer apparatus 100 for the unrolled sensor device 200 have been
drawn into FIG. 3C with dashed lines.
[0114] In one embodiment, the plurality of radiation entrance
regions 230 forms a one-dimensional arrangement 231 of radiation
entrance regions 232-x, for example, oriented in the direction of
the circumference 104, that may extend over part of the
circumference or, in one or more exemplary embodiments, also
essentially over the entire extension along the circumferential
direction 104 of the sensor device 200. In an embodiment that may
be realized additionally or as an alternative, a plurality of the
radiation entrance regions 230 forms a second one-dimensional
arrangement having a plurality of radiation entrance regions 234-y
that may extend over a part of or, in one or more exemplary
embodiments, essentially over the entire extension of the sensor
device 200 along the direction of the longitudinal axis 102. In an
additional embodiment, the radiation entrance regions 230 form a
two-dimensional arrangement 235 having a plurality of radiation
entrance regions 236-x,y that may be disposed in a regular
arrangement orientated in a direction oblique or parallel to the
direction of the circumference 104 and the direction of the
longitudinal axis 102, for example, a rectangular lattice
arrangement, or may also be disposed in an irregular form. Here,
this two-dimensional arrangement 235 or lattice arrangement extends
over a part of or, in one or more exemplary embodiments, also
essentially over the entire surface of the sensor device 200. The
arrangement of the radiation entrance regions need not extend over
the entire sensor device, but rather may also be present only in
partial regions that are of particular interest.
[0115] Arranged in each radiation entrance region 230, 232-x,
232-y, 236-x,y, is either a radiation receiver, in particular a
light detector, or the entrance of an optical light guide or a
light-conducting fiber. In the latter case, the optical light guide
or the light-conducting fiber conducts the light that has entered
into the optical light guide or light-conducting fiber through the
optical light guide or light-conducting fiber to a radiation exit
region on the opposite end of the optical light guide or
light-conducting fiber, where a light detector is provided that
detects light exiting the optical light guide or light-conducting
fiber. Depending on the measurement task and light intensity or
wavelength to be expected, each light detector may be one of the
following: a photodiode, a phototransistor, a CMOS light detector,
a photomultiplier, or an avalanche photodiode. In the embodiment
with optical light guides or light-conducting fibers, the light
exit ends may be combined to form a lattice arrangement congruent
to the arrangement of the light entrance openings and the light
exiting from the plurality of these exit openings may be measured
on a correspondingly arranged or equipped one- or two-dimensional
light detector, for example, a one- or two-dimensional CCD sensor,
in its spatial distribution and with regard to its intensity.
[0116] Corresponding to the spatial arrangement of the radiation
entrance regions 230 in one-dimensional arrangements 231, 233 or in
a two-dimensional arrangement 235, the plurality of radiation exit
regions 250 may be designed in one of the following arrangements: a
one-dimensional arrangement 251 of radiation exit regions 252-x
that are distributed along the direction of the circumference 104
and that extend essentially over the entire extension of the
unrolled sensor device 200, a one-dimensional arrangement 253 of
radiation exit regions 254-y that are distributed along the
direction of the longitudinal axis 102 and that essentially extend
over the entire extension in this direction of the unrolled a
sensor device 200, and/or a two-dimensional arrangement 255 of a
plurality of radiation exit regions 256-x,y that are disposed in an
essentially rectangular lattice arrangement oriented along the
direction of the circumference 104 and the longitudinal axis 102.
Either a light source such as an LED or an exit opening for the
exit of light from an optical light guide or light-conducting fiber
conducting light may be disposed in each radiation exit region 250.
In the embodiment with optical light guides or light-conducting
fibers conducting light, a separate light source may be disposed on
the opposite end of each optical light guide or light-conducting
fiber. Alternatively, the radiation exit regions 250 may also be
combined in a lattice arrangement, for example, congruent to the
lattice structure of the radiation entrance regions 230 and may be
illuminated by a plurality of radiation sources or even by one
single light source that, for example, emits a homogenous radiation
field or parallel light, such as an expanded laser beam. Other
light sources may be used as well, for example, such as one or more
halogen lamps or other lamps, fluorescent light sources, or the
like. If multiple light sources are used, the light sources may be
switched on and off individually in one, multiple, or all exemplary
embodiments, such that a targeted and controlled irradiation may be
conducted.
[0117] As a person skilled in the art will easily see, different
light irradiation distributions and/or illumination geometries may
be realized by the selective activation or radiation emission from
the radiation exit regions 250. By the selective measurement of
radiation intensities in selectively chosen radiation entry regions
230, various radiation or illumination configurations of light from
the housing 110 of the dialyzer apparatus 100 may be realized.
[0118] In the embodiment in which radiation is conducted from the
radiation entry regions via an optical light guide and/or a
light-conducting fiber to a detector located at a spatial distance,
a light measuring unit may also be provided behind the light exit
region from the optical light guide and/or light-conducting fiber
that may comprise a wavelength selection unit such as a
monochromator and a light detector disposed therebehind. The
wavelength selection unit may be designed to select a narrow
wavelength range that includes a predetermined detection or
measurement wavelength.
[0119] For example, a narrow-band wavelength range of measurement
wavelengths may be realized or scanned in such a way that a
luminescent or fluorescent emission spectrum may be detected. A
person skilled in the art knows that a luminescent, fluorescent, or
fluorescence emission spectrum is characteristic for a selected
material that is dissolved, for example, in the blood region 130 or
in the blood, or in the dialysate region 170 or in the dialysate.
Here, in one or more exemplary embodiments, such a luminescent or
fluorescent material may be applied to the housing that is able to
identify the dialyzer. Thus, the type of dialyzer may be recognized
that is currently inserted, currently being used, or to be
used.
[0120] FIG. 4 shows how a dialyzer apparatus 100 according to the
third aspect of the invention and a sensor device 200 according to
the second aspect of the invention may be integrated into or
connected to a dialysis machine 300 according to the fourth aspect
of the invention with regard to control and/or reading and
conducting of measurement and control signals. The dialysis machine
300 shown in FIG. 4 comprises the components of the dialysate
circuit 40 and the blood circuit shown in FIG. 1, which are not
shown in detail in FIG. 4.
[0121] The dialyzer apparatus 100 is fluidically integrated into
the dialysate circuit 40 of the dialysis machine 300 via the
dialysate supply 72 and the dialysate discharge 78 shown in FIG. 1.
Moreover, the dialyzer apparatus 100 is connected to the arterial
access 22 and the venous access 36 of the patient 10 via the
arterial tube system 24 and the venous tube system 34, see FIG.
1.
[0122] The dialysis machine 300 shown in FIG. 4 comprises a machine
housing 302 in which the components of the dialysate circuit 40
shown in FIG. 1 are disposed, with the exception of the dialyzer
apparatus 100. The dialyzer apparatus may be disposed inside the
machine housing 302 or externally thereto. In the case of an
external arrangement, the dialyzer apparatus 100 is in fluidic
communication with the components of the dialysate circuit 40
disposed inside the machine housing 302 via the dialysate supply 72
and the dialysate outlet 78, see FIG. 1. The machine housing 302
comprises housing rollers 304, 304' with which the machine 300 may
be rolled along a floor. A data output and/or visualization unit
310 and a data input unit (not shown) are provided disposed on the
machine housing 302 or at a distance therefrom and connected via
the corresponding data lines. The data input unit and data output
and/or a visualization unit 310 combine to form an input/output
unit that may be structured in any manner corresponding to the wide
variety of modern human-machine interfaces known to the person
skilled in the art.
[0123] The dialysis machine 300 also comprises a control unit 320
that is designed to control the components of the dialysate circuit
40, the radiation transmitting unit 210 and its components, as well
as to control the radiation measuring unit 240 and its
subcomponents, a data processing and/or analysis unit 330 that is
designed to receive the measurement signals generated by the sensor
device 200, to convert said signals into relevant parameters,
analyze them, and provide them for storage and/or backup, and a
storage unit 340 that is designed to receive and store measurement
data provided and/or analyzed by the data processing and/or
analysis unit 330, and in particular also computer programs that
control the controlled unit 320, the data processing and/or
analysis unit 330 and/or the input/output unit 210.
[0124] The dialysis machine 300 moreover comprises a data bus
system 360 at which the control components of the dialysate circuit
40 and the blood circuit 20, the units 310, 320, 330, 340 shown in
FIG. 4, and the dialyzer apparatus 100 and the sensor device
removably attachable thereto are communicatively connected to one
another. The data bus system 360 comprises an input/output data
line 362 with which the input/output unit 310 is communicatively
connected, a control line 364 with which the control unit 320 is
communicatively connected and made able to receive data from the
input/output unit 310 and the transmit control data and/or analyze
data to the input/output unit 310, for example, to be output as a
display, an operating data line 366 with which the control unit 360
and the data processing and/or analysis unit 330 are
communicatively connected to one another, a data storage line 368
with which the storage unit 340 and the data processing and/or
analysis unit 330 are communicatively connected to one another, the
dialyzer apparatus signal line 370 with which the dialyzer
apparatus 100 and the dialysis machine 300 are communicatively
connected to one another, and a sensor device signal line 372 with
which the sensor device 200 and the data processing and/or analysis
unit 330 of the dialysis machine 300 are communicatively connected
to one another.
[0125] The dialyzer apparatus 100 is connected to the control unit
320 via the dialyzer apparatus signal line 370 and the sensor
device 200, which is removably attachable to the dialyzer apparatus
100, is communicatively connected to the data processing and/or
analysis unit 330 of the dialysis machine 300 via the sensor device
signal line 372. Via the sensor device signal line 372, the data
processing and/or analysis unit 330 is able to transmit measurement
data, for example, measured radiation intensity data or
identification data, generated by the sensor device 200 to the data
processing and/or analysis unit 330 for processing and analysis as
well as receive control data for controlling the radiation
transmitting unit or units 240 from the control unit 320. Via the
dialyzer apparatus signal line 370, the dialyzer apparatus 100 is
able to receive control signals from the control unit 320 and,
conversely, transmit information that is characteristic for its
state and/or identification to the control unit 320.
[0126] The dialysis machine 300 shown in FIG. 4 moreover comprises
a first housing holder 180 and the second housing holder 182. These
housing holders are designed to carry the dialyzer apparatus 100
between them in a removably insertable fashion. The first housing
holder 180 and, optionally, the second housing holder 182 may be
designed as end caps to be removably placed on the respective end
of the dialyzer apparatus 100 and, in particular, to be reusable,
while the dialyzer apparatus 100 as a whole is designed as a
single-use article. Here, the housing holders 180, 182 serve to
fluidically integrate the dialyzer apparatus 100 into the dialysate
circuit 40 and the blood circuit 20. The sensor device 200 may be
permanently connected to the first or second housing holder 180,
182 or maybe designed separately therefrom.
[0127] In one embodiment, the first housing holder 180 is connected
in a fixed fashion to the housing 110 of the dialysis machine 300
and the second housing holder 182 is designed as a separate part
that is removably attachable, for example, clipable, to the
dialyzer apparatus 100 and also removably attachable, for example,
clipable, to the machine housing 302. In another embodiment, only
one single housing holder 180 is provided that holds the dialyzer
apparatus 100 in a removable, for example, clipable, and reliable
fashion. In yet another embodiment, the dialyzer apparatus 100 and
the housing holders 180 and 182 are used at a remove from the
dialysis machine, for example, near the patient 10 to be
treated.
[0128] It is obvious to the person skilled in the art that the
sensor device 200, in particular in the embodiments described in
FIGS. 2A-C and 3A-C, as a whole may be designed in such a way that
the following functions and/or concretely structured optical
measurements may be conducted at the dialyzer apparatus 100. The
functionality of the sensor device 200 shown in FIGS. 3A-C may, for
example, be completely adapted for the following tasks: [0129] (i)
measurements in the blood region 130 for determining the
concentration of materials such as, for example, albumin, other
materials, or uremic toxins, in the blood, [0130] (ii) measurement
of physical parameters of the blood in the blood region 130 and/or
the dialysate in the dialysate region 170, for example, viscosity
and/or flow rate of the dialysate and/or the blood or the
hematocrit concentration in the blood, and [0131] (iii)
measurements in the dialysate region 170 to determine the
concentration of materials such as, for example, proteins, other
materials, or uremic toxins in the dialysate.
[0132] Exemplary embodiments of optical measurements that may be
conducted using the sensor device 200 will be described in the
following.
[0133] In one, multiple, or all exemplary embodiments, measurements
may be conducted on the dialyzer apparatus. This will be described
in further detail below.
[0134] A light source is provided that is, for example, built into
the sensor device 200 described with reference to FIG. 2A-C or
optically connected thereto via optical light guides and/or
light-conducting fibers; said light source emits narrow-band light,
for example, an LED, a laser beam, or a polychromatic or
monochromatic light-guiding optical light guide and/or
light-conducting fiber. This light source shines light, optionally
via a beam-forming element, for example, a collecting lens,
vertically or at a predetermined angle through a transparent area,
for example, a window region 114, 116, 118, into the internal
volume portion 120 of the housing 110. The projected light impacts
in the region of the dialyzer apparatus 100 in which the membrane
of the membrane filter device 190 is disposed with its membrane
fibers. A light detector is integrated in the spatial vicinity of
the light source into the sensor device 200 or optically connected
thereto via an optical light guide and/or light-conducting fiber,
said light detector capturing light scattered or reflected into its
field of view that is reflected, for example, on the housing, on
the boundary surface between the housing and the fluid, or in the
region of the internal volume portion 120 illuminated by the light
source. This light detector may be one photodiode or a plurality of
photodiodes or also another type of detector such as a
phototransistor, a CMOS detector, a CCD, a photomultiplier, or an
avalanche photodiode.
[0135] A one-dimensional arrangement 231, 233 or a two-dimensional
arrangement 235 of light detectors and/or light entry openings
(radiation entry regions 230) is distributed over the interior side
of the sensor device 200 having the input ends of optical light
guides and/or light-conducting fibers, whose light input bevels
point in the direction of view from which the light radiation to be
analyzed comes. The optical light guide and/or light-conducting
fibers serve to conduct the light to be analyzed out of the sensor
device 200 to another place to be analyzed, for example, with the
light detectors mentioned above, optionally in combination with
wavelength selection units (for example, monochromator(s)). The
selection of measurement wavelengths allows the selection of
materials dissolved in the dialysate and/or in the blood with which
the analyzed light has interacted. The entry and/or exit of the
light may also occur at an angle to the surface of the housing; in
such a case, the light detectors or optical light guides may be
disposed obliquely to the surface of the housing.
[0136] For example, in the green spectral range (500-600 nm), the
light primarily interacts with the hemoglobin in the blood.
Hemoglobin has absorption bands in this spectral range. In the
infrared spectral range, glucose (for example, at the wavelength
2.3 .mu.m) and urea (for example, at a wave number (reciprocal
wavelength)) contained in the blood absorb in the range of
approximately 4500 to 4700 cm.sup.-1.
[0137] In the radiation inlet regions 230 of the sensor device 200,
it is also possible for one or more radiation measuring units 220
to be disposed having a measurement optic unit with a focus and/or
focal direction and a light detector having a light-sensitive
detector surface. Here, the measurement optic unit may be designed
to map a spatial region from the internal volume portion 120, for
example, from the blood region 130 or the dialysate region 170 onto
the detector surface of the light detector, with the spatial region
to be mapped being defined by adjusting the focal depth and focal
direction. By changing the focal depth and optionally also by
changing the focal depth of the detected light, the area of the
internal volume portion 120 in which an optical interaction occurs
may be selected. A specific analyte to be detected may be selected
by selecting the measuring wavelength.
[0138] In the interactions of reflection, absorption, and
transmission, the wavelength of the analyzed light is equal to the
wavelength of the projected light beam. In one or more exemplary
embodiments, the light beam may be projected essentially vertically
onto the housing wall 112 of the dialyzer apparatus 100 and
analyzed in the same direction or even at a right angle (or a
virtual right angle) thereto, for example, if fluorescence
properties are used. In this measuring arrangement, a low intensity
of analyzed light may indicate the presence of a high degree of
absorption, which in turn allows conclusions to be drawn on the
concentration of a material or mixture of materials, for example,
causing absorption. Thus, a change over time and spatial
distribution of the absorption may be detected and thus a spatial
distribution and/or a change over time in a material concentration
may be measured.
[0139] Alternately or additionally, in one, multiple, or all
exemplary embodiments, fluorescence and/or luminescence
measurements may be conducted on the dialyzer apparatus. This will
be described in greater detail below.
[0140] If the wavelength of the analyzed light beam is a different
wavelength, for example longer wavelength, then that of the
projected light beam, the measuring arrangement described above may
be used with a scattering arrangement of the direction of view of
the light detector relative to the projection direction of the
light source at a corresponding intensity and selection of the
wavelength of the projected light beam, for example, in the
ultraviolet (UV) spectral range, to measure and optionally also
quantify fluorescent and/or luminescent interactions induced with
materials dissolved in the blood or in the dialysate. Here it is
possible in one or more exemplary embodiments for the light beam
inducing the interaction to be projected in brief and, for example,
high-intensity, pulses of light and to detect the light generated
and/or spectrally dispersed as a result of the fluorescent and/or
luminescent reaction. Such fluorescence and/or luminescence
measurements allow conclusions to be drawn regarding materials
dissolved in the dialysate and/or in the blood as well as their
concentration and spatial distribution. This allows a time-resolved
measurement in which the decay time of the fluorescence is measured
as a characteristic.
[0141] Instead of pulses, a continuous illumination may also be
provided.
[0142] In one or more exemplary embodiments, the detector is
disposed at an angle, for example, at a right angle to the light
incidence direction, such that the measurements are disturbed by
reflections either negligibly or not at all.
[0143] In one, multiple, or all exemplary embodiments, the
refraction of light radiation at the dialyzer apparatus may be
analyzed. This will be described in greater detail below.
[0144] The possible structures of light irradiation and light
detection from example 1 apply here correspondingly. Concretely,
they may be used to measure light refraction at the dialyzer
apparatus 100 as follows:
[0145] Irradiated light radiation is projected in a well-defined
direction onto the housing wall 112, not vertically but rather at
any desired oblique angle on the housing wall 112. Light refraction
occurs at the boundary surface between the housing wall 112 and the
dialysate or the blood as well as at all other boundary surfaces in
the internal volume portion 120 of the dialyzer apparatus 100. As
is known to the person skilled in the art, these refractions depend
on the refraction index of the materials present at the boundary
surfaces. Due to their concentration and their strong optical
interactions, the optical properties of the dialysate and the blood
have the greatest effect on light refraction. The measurement of
light refraction may therefore be referred to for the analysis of
physical properties of the dialysate and/or the blood, for example,
to measure their density.
[0146] The detection of refracted light radiation exiting the
dialyzer apparatus 100 after refraction may occur in a
space-resolved fashion at a site of the sensor device 200 different
from the irradiation site. The location of the detection, for
example, by selectively choosing active light entrance openings
256-x,y in the two-dimensional arrangement 255 in FIGS. 3A-C, and
the irradiation direction and location of the irradiated light may
be coordinated with one another such that the angle of refraction
undergone in the course of the light refraction from the position
of the detected refracted light within the two-dimensional
arrangement 255 of the radiation entrance openings 256-x,y may be
inferred. From this, the complex refraction index may be inferred
and, in turn, the physical properties of the liquids in the
dialysate and/or in the blood influencing the refraction index, for
example, their density, may be inferred. In order to infer of the
complex refraction index, in one, multiple, or all exemplary
embodiments, the deflection of the beam and the loss of intensity
upon passing through the medium (absorption) is detected. The real
part is determined by the deflection, and the imaginary part by
absorption. Medically relevant parameters may be derived from the
physical properties, such as the hematocrit concentration in the
blood.
[0147] In one, multiple, or all exemplary embodiments, it is also
possible for transmission measurements to be conducted on the
dialyzer apparatus. This will be explained in greater detail
below.
[0148] If the view direction of a detector in the sensor device 200
is placed at one site and oriented on the irradiated incident light
beam, it is possible to determine an absorption coefficient along
the path traveled by the light beam from the dampening and/or from
the removal from the light beam upon traveling a path in the
internal volume portion 120, for example, in the blood region 130
or in the dialysate region 170. If the light beam is selectively
measured with regard to the absorption wavelength, the selection of
the measurement wavelength allows a material-specific absorption to
be measured and a concentration of the corresponding material in
the space along the path traveled by the light to be inferred. Such
transmission and absorption measurements allow conclusions to be
drawn regarding the material composition of the dialysate and/or
the blood.
[0149] In one, multiple, or all exemplary embodiments, a
measurement of scattered radiation may be conducted at the dialyzer
apparatus. This will be discussed in greater detail below.
[0150] With the measurement geometry described in examples 1 and 2,
light radiation scattered in the dialyzer apparatus 100 may also be
analyzed. To this end, the intensity of the scattered light may be
determined at any desired position on the dialyzer apparatus that,
if possible, is not located in the direction of propagation of the
scattered light or in the direction of propagation of the reflected
light. Preferably, the scattered light is measured at multiple
locations on the housing surface 112 of the dialyzer apparatus,
which is possible, for example, using the embodiment shown in FIGS.
3A-C of the sensor device 200 having a two-dimensional arrangement
255 of light entrance openings 256-x,y. From the intensity of the
scattered light, the presence of materials may be inferred, for
example, certain molecules whose dimensions are typically up to 10
times smaller than the wavelength of the light used. The larger the
concentration of such materials and/or structures, the greater the
intensity of the scattered radiation. From the spatial distribution
of the intensity of the scattered radiation in the different
spatial directions, the size and the shape of the materials and/or
structures (for example, molecules) may be inferred.
[0151] A special case of light scattering inducible using the
sensor device 200 is dynamic light refraction. Here, a highly
monochromatic and highly directed and/or concentrated light source
such as a laser beam is used as a light irradiation unit 210. Using
the two-dimensional light detection arrangement, such as the
two-dimensional arrangement 255 of the light entrance openings
256-x,y in FIGS. 3A-C, the spatial distribution of the scattered
light may be measured. The spatial distribution is influenced,
inter alia, by interference of the scattered irradiated light, with
light reaching the same point of the two-dimensional (planar)
detector unit from the one irradiated light beam via different
paths (scattering paths). From the measured change over time of the
interference pattern measured with the planar detector unit, the
movement of the scattering centers may be inferred. If the analyzed
scattering centers are, for example, red blood cells, their speed
may be inferred, in particular the speed of their (undirected)
Brownian motion, and from that their tendency to coagulate the
blood in capillaries of the membrane of the membrane filter device
190 and, based on that, changes may optionally be made in the
parameters of the dialysis therapy.
[0152] In one, multiple, or all exemplary embodiments, an
electromagnetic identification of a dialyzer and/or a component
thereof such as a membrane filter device. This will be explained in
greater detail below.
[0153] Electromagnetic radiation may also be used to identify the
dialyzer apparatus 100 and/or membrane filter unit 190 used in a
dialysis therapy on a patient 10 in an automated fashion. Thus, the
dialysis machine 300 may obtain information regarding the dialyzer
apparatus or membrane filter device 190 designed as a single-use
article (held, for example, by the housing holders 180, 182) used
in the dialysis therapy of a patient 10, for example, the type
and/or a serial number or some other special embodiment thereof
without medical personnel conducting the therapy being required to
enter information regarding the identification of the dialyzer
apparatus 100 and/or membrane filter device 190 used in the
dialysis therapy in a potentially erroneous fashion, for example,
via the input/output unit 310 of the dialysis machine 300.
[0154] In one embodiment, a barcode scanner, a detector, or a
camera (for recognizing a code, for example, a data matrix and/or a
2-D code or a fluorescent code) is integrated into the sensor
device 200 for this purpose, and the sensor device 200 is placed on
the dialyzer apparatus 100 in such a way that the barcode scanner
and/or the detector or the camera is able to read a code attached
or printed on the dialyzer apparatus 100 or membrane filter device
190 embodied as a single-use article, for example, a barcode and/or
data matrix and/or 2-D or 3-D code or a fluorescent code. Using
optical detectors, a color code identification may also be
realized, such as a color code attached to or printed on the
single-use article or via a colorful design of the dialyzer housing
110 or via a spectrometric and/or a true-color light detector unit,
thus realizing an identification of the dialyzer apparatus 100 or
membrane filter device 190 used in the dialysis therapy.
[0155] As an alternative to identification based on optical
detection by the sensor device 200, a communication may be
initiated based on the measurement of RF (radio frequency)
radiation with an RFID chip attached on the dialyzer apparatus 100
or on the components such as the membrane filter device 190 and
stored on the RFID chip in a manner known to the person skilled in
the art and characteristic identifying information may be accessed.
One advantage of identification with RF radiation is the fact that
the RF detector integrated into the sensor device 200 may be
designed with a very short range, for example, inductively, thus
ensuring with a high degree of certainty that only the RFID chip
attached to the dialyzer apparatus 100 currently attached to the
sensor device 200 will be read.
[0156] The embodiments of the sensor device 200 according to the
second aspect of the invention described herein and/or claimed in
the attached claims and of the dialyzer apparatus 100 according to
the third aspect of the invention allow the following advantages to
be attained in a manner obvious to the person skilled in the art:
[0157] 1) Measurements of information regarding a state, for
example, a dialysance, or a material concentration, or regarding an
identification of a dialyzer apparatus 100 or membrane filter
device 190 designed as a single-use article during operation in a
dialysis treatment of a patient 10. [0158] 2) Measurements with a
comparably high temporal resolution, for example, in time intervals
of a few seconds to minutes, that allow therapeutic interventions
for the optimization of treatment to be undertaken during an
ongoing dialysis treatment. [0159] 3) Measurements, in particular
conducted in a contact-free fashion, of information regarding the
state of the dialyzer apparatus 100 or the membrane filter device
190 directly on the dialyzer apparatus 100. [0160] 4) The sensor
device 200 is reusable and therefore cost-efficient in light of the
fact that the dialyzer apparatus 100 or at least the membrane
filter device 190 disposed therein is a single-use article. This
advantage will continue to be valid until some point in the future
when sensor equipment to be integrated into the dialyzer apparatus
100 becomes less expensive.
[0161] Multiple aspects of the exemplary embodiments will be
discussed in a numbered form below: [0162] Aspect 1 relates to a
system for detecting a characteristic or a state of a dialyzer
apparatus (100) or a component thereof such as a membrane filter
device (190) of the dialyzer apparatus (100) before or during
operation of the dialyzer apparatus (100), for example, in treating
the blood of a patient (10), with the system comprising the
following: [0163] the dialyzer apparatus (100) having a housing
(110) encompassing an internal volume portion (120) and a membrane
filter device (190) essentially disposed in the internal volume
portion (120), where the housing may be permeable at least in
regions to a signal, such as a radiation signal, and [0164] a
sensor device (200) that may be connected in a removable fashion to
the housing (110) of the dialyzer apparatus (100) and that
comprises a signal receiving unit (210, 212, 220, 222, 224) that is
designed to receive at least one signal, such as a radiation
signal, from the outside or edge region of the housing or from the
internal volume portion (120) of the housing (110), with the signal
being characteristic for the dialyzer apparatus or its state or for
the blood treatment.
[0165] Aspect 2. The system according to Aspect 1 that is designed
to provide the received signal to an analysis unit (330) that
generates data based on the received signal that may be used for
controlling the operating parameters of a dialysis machine
(300).
[0166] Aspect 3. The system according to Aspect 1 or 2, in which
the signal receiving unit (210, 220, 222, 224) is designed to
receive or detect signals of a radiation that has been selected
from a group that comprises the following: [0167] a)
electromagnetic radiation of the entire electromagnetic spectrum,
optionally with a wavelength in the optical range, for example, in
the range of far infrared, infrared (IR), near infrared, visible,
and ultraviolet (UV) light, [0168] b) electromagnetic radiation
having a wavelength or a corresponding frequency in the microwave
range, in the terahertz range, i.e., in the sub-millimeter range,
or in the range of radio waves, such as radio waves used in RFID
technology, and [0169] c) ultrasound radiation.
[0170] Aspect 4. The system according to Aspect 1 or 2, in which
the signal receiving unit (210) comprises a receiver for an
electrical signal, with the electrical signal being indicative of a
capacity to be measured and/or an inductivity to be measured that
is characteristic for the state and/or identification of the
dialyzer apparatus (100) and/or the membrane filter device
(190).
[0171] Aspect 5. The system according to Aspect 3, in which the
sensor device (200) comprises a radiation transmitting unit (240)
that is designed to transmit radiation, such as, for example, light
or ultrasound radiation, into the internal volume portion (120) of
the housing (110) of the dialyzer apparatus (100), and in which the
signal receiving unit (210, 220, 222, 224) is designed to measure
one or more parameters such as, for example, intensity, phase,
and/or behavior over time, of radiation transmitted via the
radiation transmitting unit, where the measured radiation may
optionally be the result of an interaction characteristic of the
state of the dialyzer apparatus (200) that has occurred in the
internal volume portion (120) of the housing (110) between the
radiation and one or more of the following: [0172] the dialysate
and/or the blood, [0173] a substance contained in the dialysate
and/or the blood, [0174] the membrane filter device (190), and
[0175] a material held in and/or on the membrane filter device
(190) that originates from the blood and/or the dialysate, [0176]
where at least a portion of the interacting radiation from the
internal volume portion (120) has reached the signal receiving unit
(210, 220, 222, 224), and [0177] where, in particular, the
interaction was triggered by radiation transmitted by the radiation
transmitting unit (240) into the internal volume portion (120) of
the housing (110).
[0178] Aspect 6. The system according to Aspect 5, in which an
optical interaction was triggered selected from a group that
comprises the following: [0179] reflection of optical radiation
emitted by the radiation transmitting unit (240) on a boundary
surface between the housing wall (112), for example, the window
region (114, 116), and the dialysate or the blood, [0180]
reflection of optical radiation emitted by the radiation
transmitting unit (240) on a boundary surface between the membrane
filter device (190) and the dialysate or the blood, [0181]
transmission of optical radiation emitted by the radiation
transmitting unit (240) having a measuring wavelength that can be
absorbed by a substance contained in the dialysate and/or in the
blood and, on its way to the radiation receiving unit (220), has
followed a beam path through the dialysate and/or through the
blood, [0182] emission of luminescent or fluorescent radiation by a
material contained in the dialysate and/or in the blood, with a
luminescent or fluorescent reaction in said material being
triggered by the optical radiation emitted by the radiation
transmitting unit (240), [0183] refraction of the optical radiation
emitted by the radiation transmitting unit (240) on a boundary
surface between the housing wall (112), for example, a window
region (114, 116, 118), and the dialysate or the blood, with the
transmitted radiation striking the boundary surface at an angle of
incidence between 0.degree. and 180.degree. or between 0.degree.
and 90.degree., [0184] scattering of optical radiation emitted by
the radiation transmitting unit (240) on a substance contained in
the dialysate or in the blood, including dynamic scattering of
monochromatic laser radiation, and [0185] interaction of optical
radiation emitted by the radiation transmitting unit (240) with an
identification unit (192) attached to the dialyzer apparatus (100)
or the membrane filter device (190) such as a luminescent code, a
barcode, or a color code field that comprises an identifying
feature characteristic for the identification of the dialyzer
apparatus (100) or the membrane filter device (190).
[0186] Aspect 7. The system according to Aspect 3, in which the
dialyzer apparatus (100) or the membrane filter device (190)
comprises a passive identification unit (192), such as a barcode, a
color code field, a luminescent code, i.e., a code applied with
luminescent material, or a passive RFID chip that comprises an
identification feature characteristic for the identification of the
dialyzer apparatus (100) or components such as the membrane filter
device (190) and that may be read by irradiating the identification
unit (192) with a predetermined electromagnetic radiation, [0187]
with the sensor device (200) comprising a radiation transmitting
unit (240) that is designed to transmit the predetermined
electromagnetic radiation, in particular to the identification unit
(192) and [0188] with the signal receiving unit (210) comprising an
identification reading unit (212) that is designed to detect a
parameter of the radiation that is indicative of the identification
feature and to determine the identification feature.
[0189] Aspect 8. The system according to Aspect 3, in which the
dialyzer apparatus (100) or the membrane filter device (190)
comprises an active identification unit (192), such as an active
RFID chip, that is able to transmit electromagnetic radiation
having an identification feature that is characteristic for the
identification of the dialyzer apparatus (100) or the membrane
filter device (190), and [0190] in which the signal receiving unit
(210) comprises an identification reading unit (212) that is
designed to detect the electromagnetic radiation transmitted by the
identification unit (192) and, for example, after a demodulation
analysis, determine the identification feature.
[0191] Aspect 9. The system according to Aspect 5 or 6, in which
the radiation transmitting unit (240) comprises at least one or
more of the following features: [0192] a light source that
transmits light in a narrow-band spectral range, such as a laser or
an LED, [0193] a light-conducting fiber that guides light
transmitted by a light source emitting light in a narrow-band
spectral range and a decoupling segment from which the light exits,
[0194] a light source that transmits light in a wide-band spectral
range, such as a halogen lamp, [0195] a light-conducting fiber that
guides light transmitted by a light source emitting light in a
wide-band spectral range and a decoupling segment from which the
light exits.
[0196] Aspect 10. The system according to Aspect 9, in which the
radiation transmitting unit (240) comprises a one-dimensional
arrangement (231, 233) or a two-dimensional arrangement (236) of a
plurality of light exit regions (250), in which the arrangement
(231, 233, 235) in the connected state of the sensor device (200)
and the dialyzer apparatus (100) is oriented transversely,
obliquely, or essentially parallel to a flow direction of the
dialysate in the dialysate region (170) or transversely or
obliquely or parallel to the flow direction of the blood in the
blood region (130) or transversely, obliquely, or parallel to a
longitudinal axis (102) or along the circumference of the dialyzer
apparatus.
[0197] Aspect 11. The system according to Aspect 9 or 10, in which
the sensor device (200) comprises a radiation measuring unit (220)
having a measurement optic unit having a focal depth and a focal
direction, and having a light detector comprising a light-sensitive
detector surface, wherein the measurement optic unit is designed to
map a spatial region from the internal volume portion (120) of the
housing (110) of the dialyzer apparatus (100) on the detector
surface of the light detector, with the mapped spatial region being
defined by the focal depth and the focal direction and with the
measurement optic unit being designed in such a way that its focal
depth and focal direction may be adjusted or selected before
startup or during operation in such a way that the spatial region
to be mapped inside the internal volume portion (120) is
selectable.
[0198] Aspect 12. The system according to one of Aspects 9 to 11,
wherein the sensor device (200) comprises a radiation measuring
unit (220, 260) having at least one radiation entrance region (230,
232-x, 234-y, 236-x,y) and at least one light detector that is
designed to detect radiation, such as light, that has entered into
the at least one radiation entrance region (230, 232-x, 234-y,
236-x,y) and that may be selected from a group that may optionally
include the following features alone or in any desired combination:
[0199] one or more photodiodes, [0200] one or more
phototransistors, [0201] one or more CMOS light detectors, [0202]
one or more photomultipliers, [0203] one or more avalanche
photodiodes, [0204] one or more one-dimensional or two-dimensional
CCD sensors, [0205] one or more one-dimensional or two-dimensional
CMOS sensors, [0206] one or more one-dimensional arrangements (231)
or one or more two-dimensional arrangements (235) of a plurality of
photodiodes, phototransistors, CMOS light detectors,
photomultipliers, avalanche photodiodes, or other sensors, [0207]
one or more detectors of another type such as, for example, MPPCs
(multi photon pixel counters).
[0208] Aspect 13. The system according to Aspect 12, in which a
respective radiation entrance region (230, 232-x, 234-y, 236-x,y)
comprises a coupling-in the region of an optical light guide or a
light-conducting fiber that is designed to guide the radiation to a
light detector associated with the radiation entrance region (230,
232-x, 234-y, 236-x,y).
[0209] Aspect 14. The system according to one of the previous
Aspects, in which the sensor device (200) comprises a radiation
measuring unit (220) having at least one light detector and a
wavelength selection unit, such as a monochromator, with the
wavelength selection unit being designed to select a narrow-band
wavelength range including a reference wavelength range from the
wider-band wavelength range of the radiation emitted by the
radiation transmitting unit (24), for example, light, on the
transmitting side or on the receiving side in such a way that an
optical interaction, such as absorption or excitement of
luminescent or fluorescent emissions, occurs with a selected
material located during operation on or in the dialyzer apparatus
or in the internal volume portion (120) of the housing (110), for
example, a component of the dialysate and/or the blood.
[0210] Aspect 15. The system according to one of Aspects 1 to 14,
wherein the sensor device (200) is designed to detect at least one
of the following parameters: [0211] in the blood region (30, 130)
of the internal volume portion (120), the measurement of one or
more parameters indicative of the concentration of one or more
substances such as a uremic toxin, such as the absorption of light
having one or more measurement wavelengths that are absorbed by the
substance, for example, the uremic toxin, [0212] in the dialysate
region (70, 170) of the internal volume portion (120), the
measurement of a parameter indicative of the concentration of one
or more substances, such as a uremic toxin, such as the absorption
of light having a measurement wavelength that is absorbed by the
substance, and [0213] in the blood region (30, 130), measurement of
a parameter indicative of a physical property of the blood, such as
viscosity or hematocrit concentration.
[0214] Aspect 16. The system according to one of Aspects 1 to 15,
wherein the housing of the dialyzer apparatus (100) is designed in
such a way that the sensor device (200) may be fixed in a
detachable fashion in one or more predetermined positions relative
to the housing (110), for example, in a positive fit or with
clearance.
[0215] Aspect 17. The system according to Aspect 16, wherein the
housing (110) comprises first coupling regions (111, 111') at one
or more positions on its exterior and the sensor device (200)
comprises a second coupling region (201, 201') that is designed to
engage in a positive fit with the first coupling region (111,
111'), for example, in a pressable fashion.
[0216] Aspect 18. A sensor device (200) that is designed to be
attachable in a removable fashion to a housing (110) of a dialyzer
apparatus (100) and that comprises at least one sensor for
detecting a signal originating from the interior of the housing,
wherein the sensor device in its connected state to the dialyzer
apparatus (100) is optionally able to form a system according to
one of Aspects 1 to 17.
[0217] Aspect 19. The sensor device (200) according to Aspect 18,
that comprises at least one radiation transmitter for transmitting
radiation onto the surface and/or into the interior of the dialyzer
apparatus, with the sensor device being optionally designed to be
reusable.
[0218] Aspect 20. The sensor device (200) according to Aspect 18 or
19, wherein at least one of the following mechanisms is provided
for the embodiment of the sensor device (200) to be attachable in a
removable fashion, for example, with a positive fit, on the housing
(110): [0219] the sensor device (200) is embodied as a clip unit
having at least one or more flexible clip arms or clip cuffs (210,
210'), where the clip arms or clip cuffs (210, 210') may be
designed to encompass the housing (110) in an angular range of more
than 180.degree., preferably more than 270.degree., and even more
preferably more than 320.degree., [0220] the sensor device (200)
comprises a base body and a clip unit having at least one or two
elastically flexible clip arms attached to the base body or
elastically flexible clip arms articulated on the base body
designed to encompass the housing (110) at least partially or to
enter into a fixed, removable connection therewith or, due to its
elastically flexible design or articulation, to encompass the
housing (110) in a clip-like fashion, [0221] the sensor device
(200) comprises a first member of the connector unit, such as a
dovetail unit, a screw, and/or a Velcro band, and the dialyzer
apparatus (100) comprises a second member of the connector unit,
such as a dovetail mount, a bore or screw thread designed for
screwing in the screw and/or the opposing piece to the Velcro band,
with the first member being designed to engage with the second
member or with the second member being designed to engage with the
first member in a removable positive fit, [0222] the sensor device
(200) is clamped on the housing (110) with an elastic clamping
unit, such as a rubber ring, with the clamping unit being designed
to encompass the sensor device (200) and the housing (110) of the
dialyzer apparatus (100) in its clamped state, [0223] the sensor
device (100) comprises a base body and at least one arm or a pair
of arms or cuffs articulated on the base body or connected to the
base body in an elastically flexible fashion, each comprising a
distal end region having a first member of a hook or engaging unit
provided thereon, with the arms and/or cuffs being designed to
encompass the housing (110) in an angular range of more than
180.degree., preferably more than 270.degree., and more preferably
more than 320.degree., and an elastically tensible clamping unit
having one or two end sections opposite one another, on each of
which a second member of a hook or engaging unit is provided that
is designed to detachably engage a first member of the hook or
engaging unit, with each second member on the end section of the
clamping unit being able to engage with a first member on the end
regions of the arms and/or clamps of the sensor device (200), and
[0224] the sensor device (200) is designed to be integrated into
the housing wall (112) of the dialyzer apparatus (100) in a
removable fashion, for example, in a recess or with a
protrusion.
[0225] Aspect 21. A dialyzer apparatus (100) having a housing (110)
encompassing an internal volume portion (120) and a membrane filter
device (190) essentially disposed in the internal volume portion
(120), with the housing (110) being permeable at least in regions
to a signal, for example, a radiation signal, and with the dialyzer
apparatus (100) being designed in such a way that a sensor device
may be operatively connected thereto in a removable fashion and, in
a connected state, is able to form a system.
[0226] Aspect 22. The dialyzer apparatus (100) according to Aspect
21, having at least one of the following features and optionally
having more than one or all of the following features: [0227] the
housing (100) comprises a housing wall (112), particularly in a
cylindrical shape, having at least one window region (114, 116,
118) that is permeable to a signal; [0228] the membrane filter
device (190) may be placed in the housing (100) in a removable
fashion; an interior housing may be removably fixed in the housing
(110) and essentially encompasses the membrane filter device (190),
[0229] the inner housing, in particular with the membrane filter
device (190) disposed therein, may be removably inserted in the
housing (100), [0230] at least the membrane filter device (190) is
designed as a single-use article, [0231] the inner housing and the
membrane filter device (190), or the dialyzer apparatus (100) as a
whole, are designed as single-use articles, [0232] the internal
volume portion (120) comprises a dialysate region (170) through
which dialysate is able to flow during operation and a blood region
(130) through which blood is able to flow during operation, with
the dialysate region (170) being spatially separated from the blood
region (130) by the membrane filter unit (190), [0233] the membrane
filter unit (190) is designed to allow a material exchange between
the blood and the dialysate during operation driven by
concentration gradients of materials dissolved in the blood and/or
in the dialysate, [0234] the dialyzer apparatus is designed as an
intelligent dialyzer and/or comprises interfaces to an external
control unit.
[0235] Aspect 23. A dialysis machine (300) for conducting a
dialysis treatment on a patient, having a dialyzer apparatus (100)
according to one of Aspects 21 or 22 and a sensor device (200)
according to one of Aspects 18 to 20 that are optionally provided
to form a system according to one of Aspects 1 to 17 or to be
operatively connected to such a system in a removable fashion.
[0236] Aspect 24. The dialysis machine (300) according to Aspect
23, wherein the dialyzer apparatus (100) comprises at least one
housing holder (180, 182) that is embodied separately or connected
in a fixed fashion to the dialysis machine and that is designed to
be mechanically connected to the dialysis machine at least during
operation and to fix the dialyzer apparatus (100) in a removable
fashion.
[0237] Aspect 25. The dialysis machine (300) according to Aspect
24, wherein the sensor device (200) is integrated into the housing
holder (180, 182).
* * * * *